ANZCTR search results

Hip replacement is the most commonly recommended intervention in Australia for people with severe hip arthritis, pain or fractures of hip. There are 3 different surgical approaches to replace the hip & based on the side of the hip is cut . These are from the front (anterior), back (posterior) & side (lateral). Although all 3 approaches have been proven to improve pain & function after surgery, it is still not know which approach has better muscle strength & better performance results in functional tasks like walking, stair , sit to stand etc after the surgery. Additionally some studies still report abnormalities in these functional activities regardless of which approach is used. Currently the evidence suggests the approach based on surgeon's experience & comfort. The proposed research will study patient’s muscle strength and mobility outcomes at 5 timepoints including - before surgery and after surgery at 3, 6, 12, & 24 months. The strength testing for all hip and knee muscle groups along with performance of functional tasks like walking , sit to stand , step up and down etc will be analysed using a 3D gait analysis setup. The study will also compare these outcomes between the 3 different hip replacement approaches at different mentioned at these timepoints. As a secondary outcome measure the study will compare the results of strength and functional assessment with patient reported outcome measures routinely collected as a part of normal care at the same timepoints. The results of the study will assist future clinical decisions before and after hip replacement. It may help optimising the rehabilitation and management and thus the economic costs of patients undergoing hip replacement by informing the clinicians better about muscle strength changes and its affect on functional performance at different stages following hip replacement.

Angiotensin II is an endogenous peptide that causes potent vasoconstriction and promotes the release of aldosterone from the zona granulosa of the adrenal gland. The ATHOS-3 study demonstrated that continuous infusion of angiotensin II could effectively augment mean arterial pressure compared to placebo in patients with catecholamine refractory shock. Secondary analyses suggested that angiotensin II may be of particular benefit in patients with acute kidney injury, especially in those with a high ratio of angiotensin I to II. This randomised controlled trial will examine the renal outcomes of critically ill patients with vasodilatory shock who receive angiotensin II compared to noradrenaline. Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive a continuous intravenous infusion of angiotensin II or noradrenaline until resolution of their shock. The renal outcomes and survival of patients receiving angiotensin II will be compared to those of control patients who received noradrenaline.

This single-centre single arm prospective pilot clinical study aims to demonstrate the safety of donor FMT in patients with UP resistant to 5-ASA therapy. Participants who meet study inclusion criteria and provide informed consent will receive an induction course of 6 single donor FMT enemas over 8 weeks in addition to their standard therapy. All participants will receive a 1-week course of oral vancomycin pre-conditioning prior to FMT induction. Flexible sigmoidoscopy, 3-day diet diary, stool and blood panels will be performed prior to and upon completion of FMT enema induction course. This study will primarily assess the safety of FMT enemas in patients with UP. Our study will also assess the impact of FMT induction therapy on UP disease activity utilising clinical, endoscopic, histological and patient reported outcome measures. Changes in colonic microbial composition, diversity and function post FMT therapy will be analysed.

The WA COVID-19 Immunity Collaborative (WACIC) Biobank will establish a biobank of high-quality samples from well characterised cohorts of convalescent COVID-19 cases, their close contacts, SARS-CoV-2-negative controls, immunised people, and other populations,, to support future basic science, translational and applied research, and development, optimisation and validation of diagnostic laboratory assays relevant to assessment of SARS-CoV-2 immunity.

The purpose of this study is to evaluate the effectiveness of a digital health promotion resource in promoting ergonomic ways of using technology to children aged 12 to 13 years in Australia. Specifically, it aims to determine if the resource can be effective in improving children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic use of technology. A cluster group, two-arm trial will be conducted to determine the effectiveness of the resource. Study hypothesis: The use of a digital health promotion resource can improve children's ergonomic behaviours when using technologies.

The purpose of this study is to determine whether the combination of Iberdomide, Isatuximab and Dexamethasone combined improves response to treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, you have been diagnosed with multiple myeloma and you have demonstrated disease progression within 12 months of commencing first-line therapy. Study Details Eligible participants will receive Iberdomide, Isatuximab and Dexamethasone. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of this combination of treatment of multiple myeloma patients early in the course of their disease.

Access to safe, effective pain relief is a hallmark of high quality maternity care. For women in labour the pharmacological options for pain relief have changed little in over 50 years. The choices of opioids and nitrous oxide have been reported as having a limited effect on labour pain and undesirable side effects. Epidurals provide excellent analgesia, however they severely limit mobility in labour, require advanced medical skills, close monitoring of mother and baby and can increase the risk of further medical interventions in birth. This trial will test the novel, off-label use of sterile water injections (six injections of 0.1 - 0.3 millilitres each) administered into the abdominal skin of laboring women to relieve contraction pain. Our research team’s previous work has provided definitive evidence for the effectiveness of water injections to relieve back pain (not contraction pain) in labour for approximately two hours. The injections can be repeated with no side effects. However, injections given into the back have no effect on abdominal contraction labour pain. Our proposed trial will use a randomised, double blind, placebo-controlled design to test the safety and analgesic effectiveness of water injections to relieve labour contraction pain. We will conduct survey and qualitative studies to assess satisfaction, acceptability and impact on the birth experience alongside a cost-effectiveness study. If successful, our study will provide a new option for labour pain relief that is safe, effective, cost efficient, only requiring skills available to many health care providers and ideal for women wanting to avoid the side effects of other pharmacological analgesic options. The common availability of sterile water and the simplicity of administration would make the procedure useful in regional areas and settings (e.g. homebirth), where other pharmacological analgesic options such as epidurals may not be available, and women in countries with developing health systems.

The aims of this registry are to: • Create a registry of patients with POTS to better understand the condition and its associated conditions. • Collect clinical data to support future research with the aim to: o improve quality of life and outcomes for patients with POTS o characterize disease course and reasons for the onset of POTS o characterize the health and economic burden for patients with POTS o study incidence, cause, prognosis and treatment of POTS • Collect baseline and ongoing information about POTS • Collect data on treatment for patients with POTS to report outcomes and impact of that treatment • Link data from the Medical Benefits Scheme and Pharmaceutical Benefits Scheme to determine the associated health service and economic burden associated with POTS. This will assist us to understand the economic impacts of POTS on the public health system. • Collect baseline and longitudinal health information to better understand and report treatment, health, economic, and social impacts of POTS..

The aim of this study is to investigate the efficacy of a new tracer called indocyanine green compared to the traditional radioactive tracer technetium-99m in identification and biopsy of sentinel lymph nodes for patients with breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have clinically node-negative early breast cancer, and are scheduled to undergo a sentinel lymph node biopsy. Study details Participants will receive sentinel lymph node biopsy with both indocyanine green and technetium-99m techniques. The procedure is anticipated to take up to approximately 60 minutes. After the procedure, all participants will followup in 7 days and 30 days. It is hoped that this study may demonstrate that use of indocyanine green for sentinel node biopsy is equivalent to technetium-99m, and therefore may provide a safe and effective alternative to use of a radioactive tracer for future breast cancer patients undergoing a sentinel node biopsy.

After a senate inquiry into Australian Lyme-like illness in 2016, the Australian Government released a position statement specifying that “there is a group of Australian patients suffering from the symptoms of a chronic debilitating illness, which many associate with a tick bite” and described this patient group as having Debilitating Symptom Complexes Attributed to Ticks (DSCATT). Following extensive investigations, individuals with DSCATT are usually left without a clear explanation for their illness which can lead to further distress and potentially perpetuate their disease process. Thus, DSCATT is considered a medically unexplained syndrome (MUS), and one, at current, without recognised effective treatments. There has, however, been much research into treatments for other MUS and other chronic illnesses, including specific psychology-based interventions. The aims of this pilot study are to assess the feasibility and acceptability of a tailored, 12-week, psychology-based intervention (informed by Acceptance & Commitment Therapy; ACT) for patients with DSCATT. Specifically, we aim to explore DSCATT patients’: a) willingness to participate in the study (e.g. inquiry, enrolment & retention rates); b) willingness to be consented and enrolled; c) willingness to use the strategies explored in therapy; d) attendance of patients at therapy sessions; e) follow-up and response rates to questionnaires (data collection measures) f) explore their experiences and attitudes towards treatment, post intervention