ANZCTR search results

Commercial physical activity apps (e.g., Strava) have widespread reach and accessibility, and hold great potential to increase physical activity engagement. The use of social components of such apps, in particular app-specific communities (connecting with other app users) and existing social media platforms (e.g., Facebook) have the potential to enhance physical activity. This study is a 3-arm pilot randomised controlled trial that aims to evaluate the efficacy of an intervention incorporating a commercially available app (Strava) and its associated social features (Strava community +/- Facebook) to improve physical activity levels.

The purpose of this study to determine whether the addition of selinexor to lenalidomide maintenance therapy post Autologous Stem Cell Transplant for multiple Myeloma patients increases the proportion of patients who are progression free 3 years post randomisation. Who is it for? You may be eligible for this study if you are an adult who has been newly diagnosed with Multiple Myeloma and are eligible for an Autologous Stem Cell Transplant. Study details Participants in this study will be randomised to receive either: Lenalidomide 10mg,orally,once a day for 21 days or Lenalidomide 10mg,orally,once a day for 21 days with Selinexor 40mg,orally, weekly Lenalidomide may be increased to 15mg orally, once a day for 21 days from cycle 4 onwards, provided good tolerance and no lenalidomide-related greater than or equal to grade 3 adverse events. Selinexor may be maintained at 40mg orally, weekly from cycle 2 onwards provided good tolerance and no selinexor-related greater than or equal to grade 3 adverse events Each cycle lasts 28 days, Patients will receive treatment until disease progression. During the trial patients will have blood tests performed and bone marrow samples taken to help determined the progress of the treatment. It is hoped that this research will help determine whether this treatment prolongs the progression free survival for patients, and what kinds of side effects/complications may occur with this treatment.

What is the problem? Esophageal food bolus is a common emergency. Majority of food boluses pass spontaneously or can be managed medically. However, in 10-20% of cases, endoscopic retrieval is necessary. However, endoscopic removal of food bolus can be challenging, due to limitation of working space within the esophagus, direct visualization of food bolus, the type or size of the food bolus and the endoscopic devices utilized. As a result, this may lead of failure or incomplete removal of food bolus and increase patient’s morbidity, even mortality. What is this study? We propose to assess the effectiveness of the transparent cap- assisted device, as a novel endoscopic technique in the management of food impaction in the esophagus in comparison to conventional endoscopic methods, given its usefulness has not been formally assessed in large randomized controlled studies to date. What is the significance of this study? We aim to compare a new technique for removing a piece of food which has become stuck in the esophagus using a transparent cap-assisted device and compare this to the established endoscopic method. We hope that this new technique will assist in complete removal of food bolus in one single piece rather than in pieces. This would reduce the time taken with patient’s safety unaltered, but this will not be known until we have completed with this research study. We hypothesized the use of a transparent cap allows complete en-bloc removal of food bolus in a shorter amount of time and less trauma to the mucosa, as compared to the conventional techniques.

Sudden unexpected death in people with epilepsy (SUDEP) is an under-appreciated tragedy. It has devastating effects on families, friends and colleagues of those who die, and the causes of SUDEP remain unknown. We will conduct an international, multicentre, prospective, case-control study of SUDEP, recruiting participants over four years. Each centre will define a cohort from which cases and controls will be prospectively identified. The cohort will comprise people with epilepsy who have been seen at the centre since a specific date (no earlier than 01/01/2015). Cases will be people with epilepsy from these pre-specified cohorts who have died from definite or probable SUDEP (with or without other co-morbidity), or resuscitated (near) SUDEP if the patient died within 72 hours of the initial collapse. Controls will be people with epilepsy who will be individually-matched by age (±2 years), sex, centre, and enrolled in the cohort at the time of death of the case (with four controls for each case). For each case, three controls will be randomly selected from all patients in the same cohort who meet the above matching criteria, using a random number generator. A fourth control will be a proxy control, who will be a spouse, relative or close friend nominated by a true control, who is randomly selected from the true-control triplet. Use of the proxy controls will allow any measurement error associated with proxy data to be quantified and corrected for. The families of cases, the control patients, and the families of controls patients (i.e. proxy controls), will be interviewed over the phone by a research coordinator or an epilepsy fellow, using a structured questionnaire. Data from the interviews will be recorded in the EpiNet database. This will include demographic data, socio-economic factors, epilepsy factors, usual sleeping arrangements, epilepsy treatments, co-morbidities, medications, alcohol, caffeine, and cigarette use, plus the use of seizure monitors, nocturnal supervision, and/or anti-suffocation pillows. For cases, relatives will be asked about the deceased's sleeping arrangements for the night of death or for the night immediately prior to death, and whether this was different from the typical sleep arrangements. Controls will be asked questions relating to their sleep arrangements on a specific nominated night's sleep (chosen randomly to be in the two weeks prior to the interview). Data neurologists, pathologists, and coroners regarding circumstances around the death, the cause of death, epilepsy and treatment factors will also be recorded if available. The data will be analysed to identify risk factors for SUDEP. Data cleaning will be performed prior to analysis. Odds ratios will be calculated using the Mantel-Haenszel method and logistic regression to control for covariates.

There is emerging evidence that dog ownership is associated with increased levels of physical activity in children, thus it is plausible that dog ownership may provide other health and development benefits for children. Dog-facilitated play and activity increases the amount of time children spend interacting and bonding with their dog and may be an important mechanism for facilitating developmental benefits such as improved self-esteem, self-regulation, empathy, autonomy, reduced stress levels and increased attachment to their dog. A key evidence gap exists around the effect of increased interaction with companion animals via pet-facilitated play and activity and its impact on both health and developmental outcomes in young children. This study aims to pilot test companion animal-based interventions for improving children’s health and developmental outcomes. We hypothesize that strategies to increase children’s active play and walking with the family dog will improve children’s health and development.

This study will prospectively follow a group of patients who undergo ACL reconstruction with the use of a fresh frozen allograft

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.