ANZCTR search results

The study aims to determine the efficacy and safety of iron supplementation in patients with atrial fibrillation and iron deficiency. Participants will be individuals with symptomatic atrial fibrillation who meet the inclusion and exclusion criteria. After providing consent, patients will have a blood tests to identify those with iron deficiency. Those with iron deficiency will continue their involvement in the study and will be asked to complete a set of health questionnaires, and undergo a cardiac ultrasound, exercise testing, and heart rhythm monitoring. Participants will be randomised to one of two treatment groups (in a 1:1 ratio) of either placebo or ferric carboxymaltose (iron) delivered through an infusion over 15 minutes. Patients will have follow-up visits at week 4 and 8, and will undergo final testing at week 12. The trial will recruit 84 patients. It is expected that participants who receive the supplementation of iron will improve their exercise tolerance after 12 weeks compared to those who receive the placebo.

High blood pressure is highly prevalent in Australia and is known as a 'silent disease' as it usually has no symptoms until it might be too late. In recent years, there has been increasing evidence that the gut microbiome plays a role in hypertension. The gut microbiome comprises the millions of tiny microorganisms that live in our gut, and can be manipulated through the diet. We have exciting research in our lab that suggests this relationship between gut pH and blood pressure is regulated via changes in inflammation. pH is a measure of acidity from 1-14. The lower the pH, the more acidic that substance is. The higher the pH, the more alkaline and, therefore, less acidic that substance is. We believe that a lower pH in the gut, produced from the substances our gut microbes release, is associated with better control of blood pressure, and that hypertensive patients may have a higher pH than those subjects without high blood pressure. There is no research in humans that have looked at the pH of hypertensive patients specifically. The SmartPill Motility capsule is a device that measures in pH in real time, as the pill travels through the gastrointestinal tract. The Atmo Gas capsule is a device that measures gases, as well as acidic substances as they are absorbed along the gastrointestinal tract. Both of these pills will be utilised in this study. The purpose of this research is to determine the gut pH of hypertensive patients.

Breathlessness is one of the most common and troubling symptoms that people with asthma report. Breathlessness may have many causes, such as reduced lung function, an abnormal breathing pattern, vocal cord dysfunction, obesity, or anxiety. Little research has been done to understand the different causes of breathlessness in asthma or people’s experiences of breathlessness. This study will use different methods to characterise breathlessness. By doing these assessments we will better understand how breathlessness impacts people with asthma, how breathlessness differs according to how severe your asthma is, and what the multiple causes of breathlessness are. We will also gain a better understanding of the experience of people living with breathlessness that is caused by a condition known as vocal cord dysfunction. This condition is known to cause breathlessness and frequently overlaps with asthma.

This study aims to find out if having a breast MRI after being diagnosed with breast cancer might change plans for treating the breast cancer and how this might affect patient outcomes. Who is it for? This study may be suitable if you are 18 years or older, have been recently diagnosed with breast cancer and your medical team has suggested that having a breast MRI will help plan your treatment. Trial Details Participants will not need any extra or different procedures or treatments over and above the normal care which has been offered to them by their treatment team. The research team will: * Collect information to be used in the study about participants' cancer, imaging and other tests, and their treatment. * Access clinical information collected during participants' appointments with their doctor about their current cancer care and follow up. * Access participants' clinical data from other health services used or attended as part of their cancer care (e.g. radiology or surgery). This information will be collected for up to 2 years after participant registration to the study. Participants will also be asked to complete some questionnaires to help the researchers understand how the decisions about their treatment based on having an MRI have impacted on them and their lives: * At the start of the study (before MRI): Their preference for surgery/treatment, how much uncertainty they have about making decisions, and their general wellbeing (approximately 10 minutes). * After MRI : Their preference for surgery/treatment, how much uncertainty they have about making decisions, their general well-being, and the impact of the MRI on their confidence in their treatment decision (approximately 5 minutes). * After initial treatment: Their general well-being, impact of MRI on confidence in decision (approximately 5 minutes). * 12 months after registration: Their general well-being, the impact of the MRI on their confidence in their treatment decision and their satisfaction about their decision (approximately 10 minutes). It is hoped that this research will lead to the introduction of MRI as a routine method for diagnosis and informing treatment planning for women diagnosed with breast cancer in the future.

This modified prospective cohort style study design will aim to analyse and validate the use of the delta-carotid velocity time integral to predict volume responsiveness in sepsis. Appropriate volume resuscitation is a hallmark of emergency medicine practice. Optimal volume resuscitation is often complex and increasingly controversial, with wide discrepancies in practice and guidelines. A large spectrum of guidelines exist on the ‘ideal’ fluid resuscitation, the majority focusing on sepsis. The current Surviving Sepsis guidelines recommend aggressive high volume fluid resuscitation in sepsis induced hypoperfusion . Other guideline range from high volume fluid resuscitation in all sepsis patients , to a fluid challenge in septic shock only . Our study will focus on the emergency department population, with an aim to validate this test allowing use in clinical practise. We will address the critique of high patient heterogeneity in previous studies by focusing on emergency department patients with a working diagnosis of sepsis. We propose that determining optimal intravascular filling and the timing of vasopressor use would be the most frequent clinical application of this test in clinical practice, especially given current controversies in the agreed optimal fluid resuscitation of these patients.

The primary aim of the current study is to examine different ways of delivering psychological treatments for problem gambling. Namely, the study aims to compare face-to-face treatment, online self-directed treatment, and a hybrid that has both face-to-face and online components. The delivered treatment is a cognitive therapy focusing on helping the participant understand what motivates their gambling, and then deconstructing their erroneous beliefs about their preferred form of gambling, followed by teaching them skills to make better decisions in the future. While face-to-face cognitive therapy is well researched and a supported treatment for problem gambling, preliminary evidence suggests that it may be delivered efficaciously online. By directly comparing the efficacy of face-to-face with online self-directed treatment, this study will provide useful knowledge in improving treatment delivery to problem gamblers. The study also aims to complete a cost-effectiveness evaluation, comparing the costs of the various treatment options with the observed outcomes, with particular attention focused on outcomes in individuals from vulnerable groups.

In keyhole surgery, a cut is made through the belly button. Many patients do not realise this and present for their operation with unclean belly buttons. This makes it difficult for the surgeon to ensure that the skin is sterilised before making a cut and may increase the risk of an infection after the operation. Our overall aim is to determine whether providing written education to patients prior to keyhole surgery improves the cleanliness of the belly button. Before this research can occur, we first need to study a scale that enables surgeons to visually assess the cleanliness of belly buttons. To do this, surgeons will use the scale to score photographs of clean and unclean participant belly buttons. Swabs will also be used to measure the bacterial load in participant belly buttons. The scores and bacterial load will then be used to determine whether the scale is a valid and reliable measure of belly button cleanliness. This scale can then be used to determine whether education improves belly button cleanliness in subsequent research.

This study evaluated whether Attention Control Training could improve frontline police officers’ ability to focus their attention and resilience. This project randomised 470 police officers to participate in two versions of Attention Control Training. Participants completed a 7-minute computer task in which they indicate the location of a target that is positioned in the place of an angry or neutral face. It was hypothesized that Attention Control Training would lead to greater situational awareness and less posttraumatic stress.

Osteoarthritis (OA) of the midfoot is a painful and disabling condition affecting 1 in 8 people aged over 50 years. Despite the high prevalence and burden of midfoot OA, there is very little evidence to guide the non-surgical management of this condition. Rocker sole shoes are a type of footwear designed to ‘offload’ the painful midfoot and despite anecdotal evidence to support their use in clinical practice, their efficacy has not been thoroughly investigated. Our multidisciplinary team will conduct a pilot randomised controlled trial (RCT) to gather information on feasibility and investigate the potential benefits of rocker sole footwear for painful midfoot OA, which is necessary to plan a rigorous RCT. Adults with painful midfoot OA (n=30) will be randomly allocated to receive either a pair of rocker sole footwear or standard footwear for 12 weeks. This study will assess key outcomes relating to trial feasibility (primary outcomes: recruitment, intervention use and adverse events) and if the footwear affects pain levels, foot-related disability and midfoot joint structure on MRI.

Fundoscopy (looking at the back of the eye) is extremely valuable but rarely done as the traditional direct ophthalmoscope is hard to use. The consequence is delay to diagnosis or missed diagnosis of potentially critical eye and whole body conditions. Digital fundus photography has been demonstrated as a superior alternative to direct ophthalmoscopy, detecting problems amongst 10-18% of relevant emergency department (ED) patients in metropolitan hospitals. We aim to determine how often fundus photography improves the management of patients, and the prevalence of fundus pathology in a regional setting. We hypothesise that fundus photography will: 1. change the management of patients in the ED; 2. be more accurate in diagnosis than direct ophthalmoscopy; 3. detect a rate of pathology similar to that found in metropolitan EDs.