ANZCTR search results

Proof of concept. We would like to explore the feasibility of implementing a build a self-sustaining walking group of similar people from the rheumatology outpatient clinic with musculoskeletal conditions living with chronic disease who are motivated to improve their lifestyle. In addition, to increase the physical activity levels & self-efficacy with exercise for rheumatology physiotherapy outpatients. We hypothesise that Joint Walkers will increases in walking activity, and Achievement of Performance of physical activity guidelines. We also hope to increase the patients self-efficacy with exercise & engage with others of similar health conditions in a supportive environment

Preterm infants develop respiratory distress syndrome (RDS) soon after birth due to immaturity and lack of surfactant. Several studies have demonstrated the effectiveness of artificial surfactant treatment in improving the outcome from RDS with reduced morbidity and improved survival. There is significant variation in clinical practice on how surfactant is administered. Traditionally, medications are administered to reduce pain prior to endotracheal intubation for surfactant administration. Several trials have demonstrated that the use of premedication for intubation of the newborn significantly improves intubating conditions, decreases the time and number of attempts needed to complete the intubation procedure, and minimizes the potential for intubation-related airway trauma. However, some centres continue to not use pain medications during this procedure as it can delay extubation and supress spontaneous breathing efforts of the baby. Recently, a minimally invasive surfactant therapy (MIST) has been reported and is used to administer surfactant. This method does not use premedications or endotracheal tube, instead it uses a very small catheter in spontaneously breathing preterm infants. There is limited knowledge on the effects of the different methods of surfactant administration on brain oxygen levels in preterm infants especially when premedications are not used. This observational study aims to compare the effects of three different methods of surfactant administration on brain oxygen levels in preterm infants born at 26 weeks gestation to 31+6 weeks of gestation. Once a specialist clinician in each participating unit determines the need to administer surfactant treatment, near-infrared spectroscopy (NIRS) monitoring will be started to collect data on brain oxygen levels for infants consented to participate in the study. Findings of this novel study will significantly improve the understanding and gaps in knowledge of the impact of different ways of administration of surfactant on stability of oxygen delivery to the brain as well as overall physiological stability of the baby. The study will aim to identify the best method for delivering surfactant to preterm babies with respiratory distress at birth.

The PHANTOM trial is a randomised, placebo controlled, blinded pilot trial looking at the use of prophylactic and perioperative Midodrine, in patients undergoing elective and emergency arthroplasties. This will determine if it is safe and effective in preventing clinically significant hypotension, intraoperatively and post-operatively, within a 24hr period. Patients will be followed up for 1 month following the index surgical procedure.

We hypothesise that methoxyflurane (MOF) results in non inferior pain scores on a VAS compared to nitrous oxide50%/oxygen 50% (NO2) when used by patients undergoing TVOR with conscious sedation. Both agents are proven to be effective for procedural analgesia, with good safety profiles and tolerability. While comparisons of both have been made in the settings of emergency and out of hospital medicine, no studies have assessed the two for effectiveness during TVOR. While both agents are available for use in our unit, our routine protocol used for the majority of patients calls for NO2. However benefits of MOF include portability, single use inhaler device and potentially less concern regarding occupational exposure. We therefore plan an randomised control trial to test the efficacy. In fertility, it is important to consider potential effects of any medication used on lab outcomes, which will be considered in the secondary outcomes of the study.

The aim of this research is to examine the feasibility of delivering online a previously tested therapeutic group singing intervention (ParkinSong) for people living with idiopathic Parkinson’s disease. This feasibility research will test feasibility of a) delivering the ParkinSong invention online over 12 weeks and b) collecting all data remotely with participants with Parkinson’s (n=30). The primary aim is to examine the feasibility of a fully online trial of ParkinSong by assessing recruitment, retention, attendance, safety, intervention fidelity, acceptability and associated costs. The secondary aim is to obtain preliminary information to describe the effects of ParkinSong Online on communication and wellbeing outcomes for people with idiopathic Parkinson’s. We will examine data for preliminary evidence for the efficacy of the intervention on the following outcomes: 1. speech loudness and quality 2. communication-related quality of life; 3. health-related quality of life; 4. wellbeing outcomes (depression, anxiety, stress, and apathy) In total, we aim to recruit 40 eligible participants with idiopathic Parkinson’s. Consenting participants will attend a 12-week ParkinSong Online group singing intervention. All participants will be assessed remotely pre and post intervention on a range of speech, communication and wellbeing outcomes. After the completion of the study period participants will participate in a focus group interview via Zoom to gather qualitative data about their experience of the ParkinSong Online intervention and remote assessments.

Targeted lifestyle interventions that include education, behaviour change and/or group support components could be effective in improving the lifestyle risk factors, increased falls risk and poorer mental health status associated with age-related macular degeneration (AMD). This study therefore aims to develop, implement and evaluate an online intervention through the Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program. This will be achieved over two phases: 1) a small qualitative study (semi-structured interviews) with AMD patients to determine the barriers and facilitators to participating in such a program; and 2) applying the findings from phase 1 to inform the development of the MINGLE program, followed by a pilot study to evaluate its feasibility and acceptability. Participants will be recruited from a private eye clinic in Westmead NSW. Eligible Phase 1 participants will be: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) verbally consent to participate in the study (including audio recording). Audio recordings will be transcribed verbatim by a transcribing service and analysed and coded iteratively to ensure analytic reflexivity. Key themes will be established relating to barriers and facilitators to participating in MINGLE. Eligible Phase 2 participants will be 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) able to access a smart device with a front-facing camera; 4) technically capable to use Zoom or have someone to help; 4) cleared to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire or written physician clearance for participation). Participants also agree to provided written informed consent to participate and complete the baseline questionnaire. For the intervention, participants will be divided into subgroups based on session timings (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks with each session including 10 minutes informal socialising; 30 minutes physical activity session; 15 minutes nutrition education. Descriptive statistics will be used to assess the acceptability and feasibility of MINGLE. T-tests will be carried out to assess the pre-post intervention improvement in quality of life, falls efficacy, physical activity, and dietary intakes. The baseline questionnaire will be re-administered immediately post-intervention. The primary outcomes of the questionnaire are significant improvements in loneliness. The secondary outcomes are significant improvements in quality of life, attitudes towards the intervention, falls self-efficacy, physical activity level and diet. The primary process outcome of this study is the development of a novel holistic online intervention with a focus on socialisation, physical activity, and nutrition education to specifically improve the wellbeing of people with AMD.

This study will look at the feasibility of physiotherapists using digital devices to improve mobility and physical activity in an inpatient rehabilitation setting in addition to usual physiotherapy care. It will look at the feasibility of running a fully powered implementation study in a large public hospital in order to pave way for a larger study to implement digital devices in rehabilitation for additional dosage, if this study is successful.

Systemic Sclerosis (SSc) is an autoimmune disorder in which normal tissue is replaced with scar tissue. Normally, the immune system helps to defend the body against various infections and diseases. In SSc, the immune system stimulates the cells to produce excess collagen (protein). The excess collagen is deposited in skin and other organs (heart muscle, lungs, blood vessels, skeletal muscles and joints) causing hardening and thickening of normal tissues (similar to scar formation). The prevalence of SSc is 443 per million population, and women are more commonly affected. One of the major causes of SSc-related death is right heart (right ventricle, RV) failure, and thus assessment of its function is important in determining survival. The RV is affected through primary heart muscle involvement and/or due to involvement of blood vessels supplying the heart. RV dysfunction is silent until advanced and routine investigations do not detect it at an early stage. Hence, there is a need for a safe and sensitive non-invasive technique for early detection of RV dysfunction. Advanced imaging techniques like cardiac magnetic resonance imaging show potential in detecting early abnormalities in the RV, before symptoms present. We propose to utilize this technique to detect early RV abnormalities in patients with SSc. This will identify those at an increased risk and allow initiation of disease modifying therapy, thereby improving outcomes.

This study aims to determine whether the new drug fibroblast activating protein inhibitor (FAPI) can be used to detect pancreatic cancer when tracked using positron emission tomography (PET) scan. Who is it for? You may be eligible for this study if you are aged 18 or over and have confirmed pancreatic cancer or a suspicious pancreatic mass, and have not commenced treatment. Study details All participants will undergo pre-treatment positron emission tomography (PET) scan using the novel PET tracer Fibroblast Activating Protein Inhibitor (FAPI). Absorption of the tracer on PET scan will be evaluated by a nuclear medicine physician as part of the research team. The results of this scan will only be shared with your treating doctor if there could be a change to your treatment as a result. Information from this study will help evaluate the applicability of FAPI-PET for diagnosing and detecting deposits of pancreatic cancer. The results will also help determine if FAPI can be used to carry targeted radiation therapy directly to cancerous tissue. Although this study will inform further research into such a treatment, no participants in this study will receive targeted radiation therapy via FAPI.

This is an exploratory study testing the Atmo Gas Capsule in 5 patients aged 18 years or over with active inflammatory bowel disease. The Atmo Gas Capsule is a novel swallowed capsular technology which measures gas concentrations (eg. oxygen, carbon dioxide, hydrogen, methane) in the gastrointestinal tract and sends data to an external receiver kept within 1.5 metres of the body. Intestinal gas composition is expected to reflect the gut microbiome composition. We will first exclude any intestinal strictures in patients with Crohn’s disease as strictures might increase the risk of capsule retention within the bowels. This will be done by demonstrating no strictures on a magnetic resonance enterography (MRE) scan within the past 3-6 months, or by first successfully passing a swallowed wax capsule containing a radiofrequency identifier. An externally held radiofrequency detector will be used to detect whether the wax capsule has passed out of the body after 5 days. If it does not pass within 5 days, the wax capsule will melt by itself and cause no harm, but these patients will not proceed with the study. Patients with Crohn’s disease who have a recent MRE with no strictures or have successfully passed the wax capsule will be able to proceed with the rest of the study. Patients with ulcerative colitis will not need this initial screening for strictures as ulcerative colitis does not predispose patients to intestinal strictures. Measurements will then be taken using the Atmo Gas Capsule before and after (8-12 weeks later) initial treatment of active inflammatory bowel disease and correlated with inflammatory bowel disease activity before and after treatment assessed clinically and by various means such as serum inflammatory markers, faecal calprotectin, or endoscopy. This will allow us to see if certain intestinal gas patterns can be correlated to disease activity and also see if gas patterns can help predict response to treatment.