ANZCTR search results

The purpose of this study is to investigate the long-term impact of wearing minimalist school shoes on a child’s (9 – 12 yrs) foot muscles and balance. The hypothesis, based on previous research is that over time, with no externally imposed shoe movement restrictions (such as with normal stiff school shoes) the child’s balance will improve and their foot muscles will increase in size and strength.

The Kinephonics app is a new technology to support people with communication difficulties using speech entrainment intervention technique. It is hypothesised the app, with the support from a support worker or allied health assistant, can help adults with a range of backgrounds (including stroke, developmental disorder, autism, brain injury) with improving their speech and language skills. The current study is a pilot study, which will inform the development of a future large clinical trial. The primary objectives of the study are to a) determine the acceptability and feasibility of conducting the study for a large clinical trial in the future using the Kinephonics app with support workers and allied health assistants implementing the intervention; and b) to determine the effect of the Kinephonics app on various speech and language outcomes. Following an assessment visit to capture communication outcomes, participants will be randomised to immediate intervention group or waitlist control group. Each group will receive Kinephonics® speech entrainment sessions 20-30 minutes 1-2 weekly for a total of 12 sessions within 6 weeks. Outcomes will be assessed after each intervention/usual care phase, and 1 month after all phases. fMRI neuroimaging on 20 participants with a background of a stroke before and after the intervention to identify neurological changes with Kinephonics® use is an optional component of the study. Outcomes which will be measured include: * Number of intervention sessions participants attend * Support worker and allied health assistants following the Kinephonics training and intervention requirements * Receptive and expressive language skills before and after the intervention * Speech skills before and after the intervention * Fatigue ratings after participating in the intervention * Optional functional MRI for stroke participants to measure neurological changes * Optional interview to discuss participant and family experience with being in the study

This clinical trial aims to assess the effect of a combination therapy with Venetoclax, Iberdomide and Dexamethasone for the treatment of patients with first or second relapse of Multiple Myeloma t(11;14). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with Multiple myeloma and have had 1-2 prior lines of treatment. Study details Participants who choose to participate in this trial will receive cycles of combination treatment. Each cycle is 28 days in length. The treatment is 3 products that will be used in combination. The first product, Venetoclax is an oral treatment and participants will take this from day 1 to day 28 of each cycle. The second product, Iberdomide is also an oral treatment and participants will take this from day 1 to day 21. The third product is Dexamethasone which participants have most likely had before. Dexamethasone will be taken on days 1, 8, 15 and 22. Participant will continue on the treatment combination until they are no longer responding to the therapy, or if the treatment causes too many adverse events. Safety assessments will be carried out by the Chief Investigator and trial committee. It is hoped this research will determine whether the combination of Venetoclax, Iberdomide and Dexamethasone is successful at treating people with relapsed or refractory multiple myeloma. If this combination treatment is found to be effective, it may be used to improve the health outcomes of future patients with refractory and relapsed multiple myeloma.

Osteoarthritis (OA) is a chronic and progressive condition affecting 1 in 8 Australians. Recent advancement suggests that there is a vascular (formation of new vessels) and inflammatory component associated with OA. Osteoarthritis of the knee is the most common form of OA. The risk of functional limitations from knee osteoarthritis is greater than that from any other medical condition for those aged 65 and above. Blockage (embolisation) of these newly developed blood vessels in knee OA represents a method to reduce a patient's symptoms but also delay the progression of their condition. Across Japan, USA and UK, many researchers have looked at the safety and efficacy in carrying out embolisation of geniculate arteries. These studies have shown a reduction in patient’s pain and nil adverse outcomes associated with the procedure itself. This procedure represents a potential intermediate management tool with reduction in the costs associated with total knee replacements as well as increasing economic productivity for patients and the community. This study hypothesises that patients who undergo blockage of the newly developed vessels will result in a reduction in analgesic consumption and an increase in quality of life for patients in comparison to the placebo. This study aims to compare geniculate artery embolisation with non-procedural intervention to ascertain further data and aid the growing literature in the global community for the use of this procedure as a method to manage patients with osteoarthritis. Participants will be assessed prior with a thorough clinical/medication history, physical examination and a questionnaire (visual analogue scale and Knee injury and osteoarthritis severity score) related to the patient’s experience with regards to their knee issues. Once the participant has consented and enrolled in the study. The study will randomise participants into an intervention group (those that receive the blockage of vessels) and those that do not. Both participants will be followed up post procedure at the 1 day, 1 week, 1 month, 3-month, 6 month and 12-month mark for functional and subjective assessment of the knee.

Patients admitted to the Intensive care Unit (ICU) are the sickest in hospital, and those that survive experience significant muscle wasting and poor functional outcomes. Nutrition therapy is a fundamental part of clinical care that is thought important to optimise recovery. Historically, invasive mechanical ventilation (IMV) – the insertion of a tube into the trachea to support or replace spontaneous breathing – has been a key strategy in respiratory management; however, for certain causes of respiratory failure there has been increasing use of non-invasive techniques. Current international critical care nutrition guidelines largely focus on those patients that are receiving IMV, and guidance in the setting of non-invasive ventilation (NIV) is lacking. This is partly due to limited high-quality nutritional and functional outcome data in this population group. We propose undertaking a prospective observational study to quantify both nutrition intake and physical and functional outcomes in critically ill patients receiving non-invasive respiratory support.

Following childbirth tears to the perineum (area between the vaginal and bowel) and vagina are common occurring in 80 to 90% of women. Tears to the anus (bottom muscle) known as 3rd or 4th degree tears and occur in 3.5% of women giving birth in Australia. To promote healing of these tears, medications are given to soften the stool (poo). Currently all women following childbirth who have sustained a tear to the bowel muscles (3rd or 4th degree tear) would have laxatives ordered. Several types of medications known as laxatives are prescribed however we do not know which one is the best. If you choose to be involved in the research, you will be allocated one of two laxatives that are prescribed for women following birth. The research team contact you and ask you about how easy it was to open your bowels (Poo), if you had any bowel incontinence (accidental loss of poo, gas or need to rush to the toilet for a Poo) or any concerns with healing of the wound (stitches). Information from this research will help guide development of a larger trial in the future. The research project aims to see how several types of laxatives affect 1. How easy or hard it was to use your bowels (Poo) after birth and until 3 months following the birth of your baby. 2. If you have accidental leakage of (Poo), called anal incontinence following birth until 3 months post birth. 3. Any concerns about healing of the stitches (3rd and 4th degree tear) following birth until 3 months post birth. ? The Continence Nursing team routinely provide follow up care to women following 3rd and 4th degree tears. As part of the research, and on discharge from hospital, you will only be required to provide verbal feedback to questions on three occasions, about how easy or difficult it was to use your bowels (do a poo) if you have accidental loss of poo (anal incontinence) and how the

This study is testing a new blood marker for heart cell death called cell free DNA (cfDNA). Drugs like inotropes may cause injury to the heart muscle which current blood markers are unable to detect. We will take samples of blood from heart failure patients admitted to the Coronary Care Unit (CCU) before, during and after the commencement of inotrope treatment, as prescribed by the cardiologist. We will investigate if there is any detectable damage to the heart in association with these medications by measuring the amount of cfDNA in the blood stream.

The 45 and Up Mobile Health Study will assess the effect of a lifestyle-focused text messaging program in 1,000 participants recruited from the Sax Institute's 45 and Up Study Cohort. The intervention will engage and educate participants with heart disease, or at high risk for heart disease, about improving their heart health and making better lifestyle choices. We aim to establish the acceptability and efficacy of a mobile text messaging intervention in improving healthy lifestyle behaviours in participants with heart disease, or at high risk for heart disease. We hypothesise that a texting program promoting healthy lifestyle will improve short-term health behaviours with smoking cessation, higher levels of physical activity, and heart-healthy diet, in those with heart disease, or who are at high risk for heart disease, as compared to no intervention.

With any major surgery, there are risks of complications such as lung infection or pneumonia. These risks may be greater if surgery is urgent, patients must wait in hospital, and have limited physical activity. We know that it is good to prepare physically for surgery and one way we are looking at is how best to do this with the lungs and breathing muscles. Researchers have studied breathing muscle strengthening exercises before elective surgery and know that improving strength helps prevent complications, however we need to know more about what happens in the short period of time while patients are waiting in hospital for urgent surgery. Exercising with and without specific devices may assist, however we are not sure whether this works, what is best, how much and how strong the training should be, and whether patients having surgery will want to do the training or enjoy it. In summary we want to know how to best prepare lungs before surgery in a short period of time, to know if higher-intensity exercise for the breathing muscles is better and to decide whether we could use this routinely on patients who would require urgent surgery. This study is comparing 2 groups of participants having urgent open-heart surgery, to see if there is a difference in inspiratory (breathing in) muscle strength with training. This is called inspiratory muscle training (IMT). One group will do exercises with the breathing strengthening device and one will not. All participants in either intervention or control groups will receive usual pre-operative physiotherapy and other interventions that are currently provided. It is hypothesised that short term, high-intensity IMT is feasible, safe and acceptable with patients in hospital awaiting urgent cardiac surgery. It is also hypothesised that short term, higher-intensity IMT will give a clinically significant increase in maximum inspiratory breathing pressure (MIP) from baseline.

The research aims to investigate factors that are predictive of anxiety and depression amongst those suffering from endometriosis. Additionally, the role of self-efficacy will be examined as a potential moderator for symptoms of anxiety and depression . These aims will be the focus of our online questionnaire. The research will also aim to determine how women’s self-management of endometriosis has been affected by the COVID-19 pandemic. This aim will be the focus of the semi-structured interview