ANZCTR search results

Lifestyle factors are known to affect the progression of multiple sclerosis (MS). The Multiple Sclerosis Online Course (MSOC)has been developed to deliver a widely accessible and user-friendly educational tool regarding modification of lifestyle related risk factors for people with MS. The intervention consists of arms: 1. an MS Online intervention course based delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and 2. an MS Online standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites. Both courses have seven modules delivered over six weeks. Having conducted a feasibility study, (ACTRN12621000245897. ) the purpose of this study is to test the effectiveness of the intervention course compared with the standard-care arm in a larger randomised controlled trial. The study hypothesis is that undertaking an MS Online Course delivering evidence based information regarding the modification of lifestyle related risk factors will lead to changed behaviours and improved health outcomes for people with MS.

Background Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. Furthermore, there is no current evidence of procedural benefit compared to optimal medical intervention alone (lifestyle coaching and medication) for any individuals. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS. Aim/Objectives 1. To measure the rate of ipsilateral (same-sided) stroke, and other arterial disease complications, in patients with advanced (50-99%) carotid stenosis who, for any reason, are managed using current best medical intervention alone. Reasons for a nonprocedural approach may include insufficient resources caused by the coronavirus pandemic, unproven procedural benefit, anticipated procedural futility and/or net harm, or patient refusal. We will study patients for whom carotid procedures are not possible or considered unethical and, therefore, where a randomised trial approach involving carotid procedures is inappropriate. 2. To compare the CASCOM Study rate of ipsilateral stroke for symptomatic patients with that reported in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST), and the CASCOM Study rate of ipsilateral stroke associated with asymptomatic carotid stenosis with that reported in the Asymptomatic Carotid Atherosclerosis Study (ACAS). Methods CASCOM is a prospective cohort study of current best medical intervention alone for stroke prevention in people who become patients by way of their referral for carotid imaging by a medical practitioner. It is also a multi-national, multi-specialty, collaborative, quality assurance and evaluation project. We will separate patients into those who would, and would not, have been eligible for past randomised CEA trials. We plan to study >367 symptomatic patients and >576 asymptomatic patients in the former, ‘eligible’, category and use them for hypothesis testing. We expect at least a 50% lowering of stroke rates with medical intervention alone in the CASCOM Study compared to that seen in past randomised trials. In addition, we plan to study 600 patients in the latter randomised trial ‘ineligible’ category and report their ipsilateral stroke rate over 5 years of follow-up. We will use ‘REDCap’ (Research Electronic Data Capture) for case reporting. Findings and Significance In CASCOM we expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials. If correct, CASCOM will provide new evidence that past randomised trials of CEA and CAS are outdated and elucidate new, improved standards for preventing stroke and other arterial disease complications.

Dexamethasone has been shown to effectively reduce the incidence of death in hospitalised patients with COVID-19 who require oxygen supplementation and invasive ventilation. Prednisolone is the same class of drug ( steroid) however it does not cross the placenta. therefore we wonder if we can use prednisolone instead of dexamethasone to create women with covid-19 in pregnancy and reduce risks to the baby. The TGA advise that dexamethasone is a category C drug in pregnancy, prednisolone is category A. There are no trials (published or in progress) comparing efficacy of dexamethasone versus prednisolone in the treatment of COVID-19 in pregnancy. A non-inferiority study may prove similar maternal mortality reductions with minimal fetal effects. It is expected that prednisolone will prevent deteriorating illness as well as dexamethasone without exposing the fetus to the effects of the steroids treatment.

The purpose of this open-label, single-centre pilot randomised controlled trial (RCT) is to investigate the use of supervised moderate-to-high intensity exercise in patients with un-resectable stage III non-small cell lung cancer (NSCLC) undergoing chemo-radiotherapy. Who is this study for? You may be eligible to join this study if you are aged 18 years or above, and have previously untreated stage IIIA, IIIB, or IIIC NSCLC that is amenable to be treated with radical-intent chemo-radiotherapy, as decided through a multidisciplinary meeting. What are the specific details? Participants will be randomised (i.e. allocated by chance) to receive either an exercise program for the duration of chemo-radiotherapy treatment, or chemo-radiotherapy treatment alone. The exercise program will involve 20 minutes of moderate-to-high intensity aerobic exercise 3 times per week, which will be supervised by a qualified exercise physiologist. Prior to commencing treatment and 8 weeks after commencing the study, all participants will undergo a number of tests of lung function and physical fitness, as well as completion of questionnaires regarding quality of life, depression, anxiety, and investigation of any exercise- or treatment-related side effects. What are you hoping to find? It is hoped that this study may show that moderate-to-high intensity exercise therapy is a feasible, safe, and efficacious method for improving quality of life and cardio-respiratory health in patients undergoing chemo-radiotherapy for the treatment of stage III non-small cell lung cancer (NSCLC).

Following Roux-en-Y gastric bypass, a type of surgery to induce weight loss in individuals who are obese, the size of the stomach is considerably reduced and food passes through to the small intestines faster. When food passes through the small intestines, various ‘hormones’ that are thought to assist with weight loss are released and enter the bloodstream. While this seems to be a useful effect, a proportion of patients can experience complications such as having an abnormally low blood sugar level (hypoglycaemia) or low blood pressure after eating. We think this may happen due to these patients producing more of these ‘hormones’ than others. This study will evaluate the movement of solid and liquid food that have been eaten and how it affects the amount of ‘hormones’ produced. Given the smaller size of the stomach, liquids could ‘wash down’ the solid food and increase the amount of ‘hormones’ produced. Learning about how the passage of solid and liquid food through the small intestine changes the amount of ‘hormones’ produced will lead to a better understanding these complications and help us develop new and more effective treatment. This information may also help us improve the dietary advice provided to patients who have had this surgery.

People with spinal cord injuries (SCI) experience changes in their muscles and health. One of these changes is muscle wasting typically due to disuse. One solution to reduce muscle wasting in people with SCI may be to use an eccentric-concentric strength training modality. Neuromuscular electrical stimulation (NMES) is commonly applied to muscles (using stick-on pad electrodes) to improve muscle strength in people with spinal cord injuries (SCI). This improvement in muscle strength is also thought to decrease muscle spasticity and improve quality of life. One modality that has promising results in muscle strength with lower loads is the use of eccentric contractions in combinations with concentric contractions. However, there is little research on NMES used as an eccentric-concentric mode in people with SCI. Thus, the current study is a proof-of-concept trial for the future use of eccentric-concentric training in people with SCI. The aim of the current study is to quantify the amount of force your thigh muscles produce during this type of electrical stimulation after a 6-week NMES intervention. Also, we will identify if this type of electrical stimulation produces less spasticity in the following days and after the 6-week intervention. Finally, we will identify if this type of NMES makes any changes in quality of life.

Asthma is an inflammatory disease of the airways that affects over 7% of the world’s population (Papi et al., 2018). Exercise-induced bronchoconstriction (EIB) is a type of asthma which is defined as a transient narrowing of the airways in response to exercise and affects 90% of asthma sufferers and up to 15% of non-asthmatic individuals (Bonini & Usmani, 2018). Asthma and EIB can be managed either by rapid bronchodilatation to relieve respiratory symptoms or long-term suppression of inflammation. However, frequent use of reliever medicines can lead to the user becoming tolerant to the treatment and long-term control medicines have several undesirable side effects. Dietary and supplement interventions have been reported to reduce the effects of asthma and EIB (Williams et al., 2016). These may represent a cost-saving, effective and safe method for reducing the incidence of asthmatic attacks. Anthocyanins are coloured pigments that are responsible for the colours red, purple and blue in fruits and vegetables. Current animal studies have found that after consumption of anthocyanins, inflammation was reduced, and lung function was improved (Park et al., 2007). Whether anthocyanins could improve respiratory symptoms and lung function in otherwise healthy humans with EIB is unknown. This will be the first study to determine the role anthocyanins have on lung function and inflammation in individuals with EIB.

Checkpoint inhibitors are a new and effective class of cancer treatment. Sometimes these drugs result in unpredictable and severe inflammatory side effects. We will apply techniques that have helped us understand autoimmune disease to investigate patients treated with checkpoint inhibitors, aiming to elucidate how individual genetic variation predisposes patients to side effects. If successful, this project will improve how these powerful drugs are prescribed and reduce the risk of toxicity.

Chronic kidney disease (CKD) and cardiac disease are two significant health conditions that can influence a woman’s pregnancy, however little is known about their prevalence and health impact within the South Australian population. These pregnancies are associated with significant risks of morbidity and mortality and propose a challenge to clinicians who manage them. The aim of this study is to prospectively record the incidence, prevalence, etiology, outcomes and follow up of maternal chronic diseases in the obstetric population of South Australia. This is a prospective cohort study of pregnant women with acquired or chronic cardiac or kidney disease.

This study aims to evaluate the efficacy of a novel relationships-focused family cognitive behavioural therapy intervention in reducing bullying victimisation and mental illness of adolescents. We hypothesise that Teen Connect Triple P (TCTP) will reduce bullying victimisation and symptoms of mental illness such as depression and anxiety in adolescents who participate, in addition to improving their supportive relationships. The efficacy of the intervention will be evaluated through online questionnaires before (0 months) and after the intervention (3 months), and through a 12-month follow-up online questionnaire. Adolescents will participate in the program over 6 x 1.5 hour weekly therapist led sessions conducted online via Zoom. Their parents will participate in separate sessions over the same time period. Adolescents learn how to strengthen friendships, interpret motives of peers, address issues calmly and assertively, resolve conflicts and seek help from their parents when needed. Parents learn how to support their adolescent’s friendships, listen to their adolescent’s concerns (without over-reacting or taking over), help their adolescent interpret peer motives, coach their adolescent in managing problems, and support their adolescents in making decisions and becoming independent. In each session, therapists educate participants about effective strategies through directed group discussions, skills-building exercises (modelling and role plays) and goal-setting for personal use. The TCTP intervention will be compared to an appropriate active control condition - 'The Blues program.' This is an existing cognitive behavioural program, previously found to reduce depressive symptoms compared with a waiting list control group. It is similar to the kind of psychological treatment adolescents with emotional problems would receive at an Australian mental health clinic. Both TCTP and the Blues Program could be delivered face-to-face. However, we are investigating the feasibility of delivering these interventions through facilitated online group Zoom sessions to minimise disruptions due to the current pandemic and to enable recruitment throughout Australia.