ANZCTR search results

This study will test a (one to one) diabetes self-management intervention that targets active coping with diabetes related goals, that are identified as most important to the individual throughout the intervention. We will test if this style of intervention is acceptable and effective and results in positive changes in diabetes self-management, glucose levels and well-being measures including diabetes distress. There will be the opportunity for some or all of the study visits to be completed remotely (e.g., via phone, or online platform). To be eligible for this study you will be aged from 18 to 50 years, diagnosed with type 1 diabetes for at least one year, your HbA1c within the preceding 6 months was at or above 8% OR based on your score on a diabetes distress survey. Information will be collected via surveys, medical records where possible, and some self-reported information.

Older adults admitted to acute care hospital settings often experience frailty and pain. However, frailty is not routinely assessed in hospital, and the prevalence of both frailty and pain in acute settings is not clearly understood. The proposed study will be the first to investigate the prevalence of frailty across an entire hospital in Australia, the first point prevalence study of frailty across an entire private hospital, and the first point prevalence study of current pain across an entire hospital using a technology driven assessment of pain. The aim is to conduct a point prevalence survey on frailty and pain of inpatients, in an acute adult private hospital in Western Australia, utilising a prospective single-day point prevalence survey design. Data collected will include demographic data, clinical data, and measures of frailty and pain in admitted acute care patients ages 18 years and over. Findings will provide insight into frailty and pain in older adults admitted to acute care hospital settings.

Summary of proposed research The investigators propose a prospective cohort study to determine the prevalence and severity of endometriosis in women at the time of laparoscopic treatment of tubal ectopic pregnancy. We hypothesise that women undergoing laparoscopic treatment of ectopic pregnancy are more likely to have concurrent endometriosis than the reported overall prevalence of endometriosis in reproductive-aged women of 10%. Suitable patients will be asked and supported to complete a pre-operative questionnaire regarding their general gynaecological health and symptoms of endometriosis and surgeons will complete a questionnaire regarding their surgical findings and grade endometriosis, if present, according to revised American Fertility Society classification of endometriosis. Ethical implications of research The investigators can think of two ethical implications of the research project: 1. Diagnosis of endometriosis as a result of participation in this research study may make endometriosis a pre-existing condition for the application and purchase of insurance (e.g. private health insurance or income protection insurance) in the future by the participant. 2. Diagnosis but non-treatment of endometriosis at the time of laparoscopic treatment of ectopic pregnancy. This may make a repeat laparoscopy and treatment of endometriosis necessary. The investigators believe that the safety and benefits of concurrent laparoscopic treatment of endometriosis and ectopic pregnancy has not been established and therefore cannot be part of research protocol.

Assessing the Impact of an Online Intervention (TrueNTH Testicular Cancer) on Men with Newly Diagnosed Testicular Cancer. Who is it for? If you are an adult male who has been diagnosed with testicular cancer in the last 4 weeks, and you have regular access to the internet on your home computer or smartphone you may eligible to participate in this study. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have immediate access to TrueNTH TC, an online intervention with testicular cancer-related information and peer support, and will have access for 4 weeks after initial login. Participants in the other group will have 'delayed' access to the intervention one week after study enrolment and will have access for 4 weeks after initial login. Throughout the four week study period, participants will be asked to complete the stress questionnaires at set timepoints, either online through the TrueNTH TC website or during a telephone interview. It is hoped that access to the TrueNTH TC website will reduce the stress and anxiety levels of newly diagnosed testicular cancer patients.

The research project is testing a potential new treatment for Celiac disease called IMU-856. Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. This is done by carrying out clinical research studies such as this one. To purpose of this study is to assess the safety and tolerability of IMU-856 when administered as a single oral dose as a 14-day repeat oral dose to healthy volunteers and as a 28-day repeat dose in patients with CelD.

The GenesisCare Outcomes Registry (GCOR) was established in November 2008 and is designed to improve patient care and outcomes through greater understanding of events, treatment and outcomes. The Registry collects detailed clinical, procedural and outcomes data on GenesisCare patients undergoing Percutaneous Coronary Intervention (PCI) or Cardiac Implantable Electronic Device (CIED) implantations. In order to improve the quality care and guideline compliance in Australia with National Outcome Registries, the registry aims to capture 100% of GenesisCare patients to monitor and benchmark compliance, care and outcomes, provide a national set of risk adjusted, consumer-focused and current clinical performance indicators to reflect clinical variations and patient outcomes. The registry will also inform research and the scientific community on coronary disease through publications/presentations, support evidence-based therapies, create efficiencies in healthcare and contribute to reducing mortality and morbidity.

Foods containing starches that undergo less small intestinal digestion have important implications for human health. By escaping digestion in the upper gut, starch that reaches the large bowel (resistant starch, RS) becomes a substrate for microbial fermentation and leads to higher production of short chain fatty acids (SCFA). These acids are not only integral to bowel health and protection against DNA damage, but also influence metabolism of peripheral tissues, including skeletal muscle, adipose tissue depots and liver, and contribute to the regulation and strengthening of immune system function and responses to infection. Additionally, slowing the rate and extent of amylolysis in the small bowel lowers the glycaemic response to food and improves blood glucose control, which can contribute to the prevention and management of type-2 diabetes. Western diets typically contain little RS because staple foods, such as cereals, are highly processed and contain starches that are readily digested in the upper gut. Consequently, RS intakes are commonly below half the suggested level of 20 g of RS per day for providing a range of health benefits. To help address this, we developed a wheat variety that contains high levels of amylose, a type of starch that has low digestibility compared to conventional wheat varieties. Although bread made from this wheat variety has a lower glycemic impact compared to conventional bread, its RS content has not been established. The purpose of this study is to establish the RS content of refined and wholemeal breads made from a novel high amylose wheat (HAW). To do this, we directly quantified the physiological RS content of breads made from a conventional (low amylose) wheat and the novel HAW in healthy ileostomates. It is hypothesised that the new HAW flour contains substantially more resistant starch than the control conventional wheat flour.

The purpose of the study is to compare video animation with electronic consent processes to the traditional paperbased PICF method of consent in a clinical trial. Participants will still engage and discuss the clinical trial and their participation with research staff as standard. Participants in the "parent clinical trial" i.e. the larger study looking at orthopaedic rehabilitation post total hip and total knee replacements using apple watches and applications, can opt out of the video/animation study if they chose to while remaining in the parent study. Participants in the parents study, will be randomised to either the electronic/animation consent group or the paper based consent group. The electronic/animation consent group will be emailed a link to watch a video animation that will explain the parent study. This animation goes for 8 minutes. They will then be asked to review the electronic version of the study PICF to ensure they have reviewed the legal information such as who to contact for trail questions and/or complaints. Participants in both group will answer knowledge and satisfaction questions to determine how well they have understood their participation in the parent trial and their satisfaction with the method of consent. This project, aims to determine if electronic/animation consent shows equal or improved participant understanding, saves research staff time, enhances patient satisfaction within a clinical trial.

Most of our vitamin D comes from spending time in the sun, but also a little comes from our diet. Importantly, research suggests that the amount of vitamin D that you have may affect the health of your muscles and therefore your strength, body composition and the amount of energy that your body uses at rest. However, we don’t know lots of things about this relationship and therefore we need to investigate it further. This is important because vitamin D may assist people to achieve a healthier body composition and perhaps help with the progression of exercise training (e.g., increasing muscle strength). The results of this study will help health professionals to clarify if higher levels of vitamin D are beneficial for achieving optimal muscle function and body composition.

Intervention and Objectives: -Intra-operatively measure the effect that posterior cruciate ligament (PCL) resection has on gap balancing by doing sequential flexion gap measurements before and after PCL resection using NAVIO robotic for primary posterior-stabilised total knee arthroplasties (PS TKA). -Determine if PCL resection induces a constant gap difference on the medial and lateral compartment in extension and at different flexion angles Hypothesis: Early complete release of the PCL during the exposure will change the flexion gap which will have clinical significant implication in the flexion gap balancing at the time of surgery Study Purpose; Midflexion instability has been flagged by the Australian Joint Replacement registry as an increasing cause of revision of Total Knee replacements. The aim of this study is to quantify flexion gap changes during surgery caused by releasing the PCL. It is hoped that quantifying this will allow more consistent results and improved survivorship after total knee replacement. -