ANZCTR search results

We aim to investigate new techniques in magnetic resonance imaging (MRI) pre and post airway clearance techniques (ACT). Adults with CF will be invited to participate, and to perform their usual ACT (i.e. breathing exercises to clear mucus from their airways) within the MRI under the guidance of an experienced physiotherapist. This will allow for innovative cutting edge imaging to be performed before and after the ACT are performed, to provide information on airway structure and function; specifically in regard to the movement of mucous (sputum) and trapped air, and well as dynamic function of the larger airways. This is important, as ACT are one of the cornerstone daily treatments undertaken in CF, yet to date no modern ACT has been shown to be superior, largely due to limited outcome measures. While lung imaging is appealing, until recently only computed tomography (CT) has been available to provide the necessary imaging. Unfortunately, CT exposes the patient to ionising radiation exposure which limits its use for especially functional imaging. Using MRI provides avoids radiation risk, therefore is an excellent option for structure and function imaging in relation to ACT. This is the first study of its kind, utilising novel MRI techniques. The experienced and capable research team will investigate the use of novel MRI techniques to objectively quantify lung structure and ventilation during ACT in adults with CF, providing new data in this area to assist in the understanding of ACT in the future. The MRI techniques used have the potential to also be used in other lung diseases such as bronchiectasis, COPD and asthma, and therefore this study is the beginning of a much larger research focus in this field. Aims In adults with CF: 1) Establish a protocol for the use of MRI to detect changes in lung structure and ventilation in relation to mucus movement during ACT; 2) Conduct a series of three MRI in adults with CF (n = 12) of varying disease severities before and after different ACT to explore the obtainable information including mucus movement and static and dynamic airway ventilation. Hypothesis MRI is a novel and suitable tool for the assessment of lung structure and ventilation during ACT in adults with CF, which will provide a new outcome measure for use in future larger clinical trials in this area. Each participant will complete three separate MRI scans, lasting approximately 20 minutes each, interspersed throughout the visit. They will also complete a 25 minute control period of resting breathing, and a 25 minute intervention period consisting of performing their usual ACT. The order of the intervention and control periods will be determined by randomisation. The ACT performed at each visit will be supervised by Jamie Wood and ACT will be performed according to International Physiotherapy Group for CF guidelines.

We documented in a previous study in patients with sciatica that reduced touch sensitivity in their leg prior to back surgery was associated with pain persistency 12 months after surgery. However, it is unclear if this reduced sensitivity/loss of sensory nerve function does imply structural nerve damage. The purpose of the current study is to investigate if structural nerve fibre damage exists in patients with sciatica pre-surgery; if structural nerve fibre damage is associated with loss of sensory nerve function and if the extent of nerve fibre damage may predict poor postoperative outcome. We do hypothesise that structural nerve fibre damage is associated with altered sensory nerve function In this pilot study 10 patients with sciatica and 10 healthy people will undergo laboratory sensory testing to assess their nerve function in their back and leg. In addition, tissue samples will be taken from their back and leg to determine the structural integrity of nerve fibres. Patients will be followed up at 3 and 12 months to monitor their progress.

This is a prospective randomized controlled trial to evaluate two approaches to reducing EEG electrode induced skin injury among ambulatory EEG patients. The trial is to compare skin injury related to EEG electrode application using Ten-20 paste with Tensive adhesive gel versus mixed EEG electrodes with hydrogel electrodes Research Questions are: i) Is a mixed approach to EEG electrode application (one which uses hydrogel electrodes in hairless scalp locations), a superior approach to reducing electrode-related skin injury than the standard approach across all scalp locations, among patients undergoing ambulatory EEG monitoring? ii) Does the use of the novel mixed EEG electrode approach yield equivocal quality EEG recording data and self-reported patient satisfaction when compared with the standard approach? We hope that our research will continue contributing to the development of an evidence base on the prevention and minimization of electrode-induced skin injury in the patients undergoing AEEG monitoring.

The purpose of this study is to assess the safety and tolerability of inclacumab, as well as the pharmacokinetics (PK – how your body uses the study drug) and pharmacodynamics (PD – how the study drug carries out its actions on the body). Inclacumab will be tested in 15 healthy participants aged 18 to 65 years. Participants will be administered a single doses of inclacumab as an intravenous infusion over 1 hour. Participants will then be followed up for 203 days for safety and PK/PD assessments

This study is a randomised controlled trial, comparing the participation in a Smiling Mind program with a waitlist/control group. Participants will be recruited through facebook and will be given the participation information statement outlining the research. Those agreeing to participate will be redirected to the initial survey (baseline data collection) which will be generated through REDcap survey software. Once the survey is complete participants will be randomised to either the waitlist/control group, or participation in a Smiling Mind program of their choice (sleep, relationships, or stress). Participants allocated to the waitlist group will receive an email with detailing that they will need to wait to join the program. Participants allocated to participate in the program will be sent instructions for joining the program. Participants will be asked to complete the initial survey (minus questions asking about demographics, and their experience with mindfulness practice) at two more time points: two weeks (half way), and four weeks (conclusion of the program). The data collected from the surveys at each time-point will be analysed to assess if there is a difference between the experimental and control groups. As an incentive to complete follow up surveys participants who complete all of the surveys will go in the draw win one $100 Amazon gift voucher. Throughout the study the Smiling Mind team will monitor using participant email addresses provided at baseline whether intervention participants have downloaded the application and are participating. If after 5 days participants have not downloaded the app and started engaging in the program, then the University of Newcastle team will send an email reminder. The email address will also be used to match participant responses between surveys. The data collected from interventions application usage will also be analysed to determine patterns of usage and engagement. It is hypothesised that participants who engage in the Smiling Mind program will have significantly improved well-being in comparison to the control group.

Effect of a combined Krill and Greenshell Mussel (GSM) supplement on joint health and osteoarthritis in an older adult population: A double-blind randomized placebo-controlled parallel study. The aim of this study is to assess the effectiveness of a phospholipid and omega-3 (from krill and GSM) supplement on joint health and osteoarthritis compared to a placebo (glycerol). We will test the hypothesis that supplementation with omega-3 will enhance joint health and quality of life in older adults.

This is a Phase 2 trial to be conducted in a single center in Australia to evaluate the safety and tolerability of CBL-514 Injection on subcutaneous fat of both thighs.

Coronary heart disease (CHD) is one of the leading causes of death in both men and women in developed countries. Western diets, which typically contain large amounts of animal and energy-dense processed foods, together with a sedentary and stressful lifestyle, are associated with increased risk of CHD. We aim to investigate the impact of a 1 year intensive lifestyle intervention (involving a 5:2 pesco-vegetarian diet, exercise, and mindfulness training) in 150 individuals with a recent diagnosis of stable CHD detected during a CT scan. Patients will be asked to follow a 5:2 pesco-vegetarian diet which substitutes meat for fish and includes plenty of fruits, vegetables, whole grains, legumes, nuts and seeds while avoiding processed foods, added sugar and supplements. On two non-consecutive fasting days, they will be asked to consume 2 meals a day containing approximately 500-600 kcal in total with a big emphasis on non-starchy raw and/or cooked vegetables. Patients will also be prescribed physical activity and mindfulness training. We will measure the impact of this intensive lifestyle intervention on coronary plaque volume and structure, as well as body composition, blood vessel function, blood pressure, blood lipids, glucose metabolism, and inflammatory markers, all of which are well established risk factors for ChD.

The aim of the project is to examine the underlying biology of 40 people who have been diagnosed with ME/CFS (Myalgic encephalomyelitis / Chronic Fatigue Syndrome) by their general practitioner comparing these symptoms to people who are well (controls) . We have brought together a team of clinicians and researchers to investigate ME/CFS from a multidisciplinary perspective. The diagnosis will be confirmed using the Canadian Consensus ME/CFS definition, interviews and questionnaires. We will aim to take blood samples, urine and faecal samples at times when the sufferer is experiencing what is often referred to as a ‘crash’ (a period of significant worsening of symptoms and accompanying greater impairment). Another set of samples will be taken when the person is feeling relatively well. A series of questionnaires will be used to obtain information about symptoms and experiences. We will examine the differences in the blood, urine and faecal samples across these two times. Samples will be taken as early as possible to allow for fasting i.e. between 8am and 10am to be negotiated with participant. There are no interventions or medications involved in this research. The most invasive aspects of the research is 2 sets of blood samples (51mls occasion 1 and 36mls occasion 2) and some questionnaires. This is an observational study.

This study will assess the feasibility (can it be done?) and acceptability (is it a helpful thing to do?) of short electronic surveys called patient reported outcome measures (PROMS) in the ongoing treatment of Stage III melanoma patients. Who is it for? If you are an adult who has been diagnosed with Stage III melanoma (with lymph node involvement) at least 3 months earlier and you are being treated at the Sydney Melanoma Surgical Oncology clinics at either the Royal Prince Alfred Hospital, or the Melanoma Institute of Australia, you may be eligible to participate in this study. Study details Participants enrolled in this study will be asked to complete a series of 2-5 health-related surveys about their quality of life on an iPad prior to their scheduled clinic appointments. Participants will receive instructions on how to complete the surveys, and will be provided with assistance from a nurse or the research project manager as needed. It is anticipated that completion of the surveys will take no more than 30 minutes before each appointment, and participants will be asked to complete either 2 or 5 surveys before 4-5 clinic visits over a 12 month period. At the end of the 12 months, all participants will be asked to complete a short survey and some will be invited to attend a one-on-one study interview with the research project manager to discuss their involvement in the study, and whether they found the surveys helpful in their discussions with their doctors. It is hoped this research may be used to improve health outcomes for patients with Stage III melanoma by highlighting patient-important outcomes following surgery, including symptoms, and quality of life issues that are central to assessing the value of melanoma care from a patient’s perspective.