ANZCTR search results

Prior to the COVID-19 pandemic there was growing recognition that at-home health monitoring programs based on a digital technologies could be used to empower community-based COPD patients to independently monitor their symptoms and act on rapid declines in health status. The 'SPHERE COPD' study is an early pilot study aims to test the feasibility and user-friendliness of a newly developed portable and patient-operated disease monitoring system in a community setting, Centered around a novel smartphone application ("app"), patients can take daily measurements of their lung function, oxygen levels in their blood and track their symptoms and rescue medication use. the app will summarise the data for the participant and securely transmit it to a server for interpretation by a healthcare professional. Deteriorations in participant condition potentially indicative of an exacerbation may be identified by the healthcare professional and queried via a telephone call. The downstream implications this study to completion are broad but have the potential to alter current approaches to COPD in the community. It may empower the individual to proactively identify an exacerbation and seek early medical assistance. It may also enhance their care by s providing physicians to access to longitudinal data on their patient’s condition between visits provides a powerful new tool with which they can more accurately tailor pharmacotherapies and written COPD action plans to optimise long-term outcomes.

This study will compare clinical and quality-of-life outcomes for breast cancer patients undergoing sub-pectoral vs. pre-pectoral implant-based breast reconstruction post mastectomy Who is it for? You may be eligible to join this study if you are aged 18 and above, diagnosed with stage 0-III breast cancer and planning to undergo nipple or skin sparing mastectomy with immediate reconstruction (as recommended by your treating breast surgeon). Study details All participants in this study will be asked to provide access to their medical records regarding baseline demographic data (such as age, weight, smoking status) and any medical complications related to their breast reconstruction surgery. They will also be asked to complete a series of short surveys designed to assess quality of life and aesthetic outcomes. The data gathered will be used to compare clinical, quality of life and aesthetic outcomes between a groups of women who have one type (pre-pectoral) of implant-based breast reconstruction to another type (sub-pectoral) implant-based breast reconstruction. Participants will not be required to attend any additional appointments beyond their routine follow-up appointments at three months, one year and two years. The PRASE Study is the first study to compare these two techniques of breast reconstruction in an Australian population. It is hoped that this research will contribute to improving health outcomes for patients with breast cancer.

There has been a significant increase in the number of children and adolescents presenting with deliberate self-harm to hospital emergency departments, highlighting the urgency of this problem, which also presents a high service burden in both the acute and sub-acute medical and mental health services in addition to personal and societal costs. This Trial sits within the context of a broader project looking to improve our understanding of deliberate self-harm in this population, which is at higher risk of death by suicide. The PCH EXPAAND (EXploring Psychiatric and Attentional comorbidities in Adolescents and children Needing intervention for Deliberate Self-Harm) aims to address significant identified knowledge gaps in our understanding of the psychopathology associated with DSH. The project will explore specific aspects of attentional spectrum comorbidities and attentional spectrum difficulties, each of which has been identified as elevating risk of DSH. This trial component of the broader project is assessing the impact of expanded and Therapeutic Assessment on rates of re-presentation to hospital emergency departments, as well as engagement with subsequent treatment and clinical presentation. We hypothesize that patients in the expanded assessment group and the expanded assessment, plus therapeutic intervention group will experience reduced clinical symptoms (episodes of DSH), improved engagement of treatment and reduced health service usage than those that receive clinical care as usual, with the therapeutic intervention group showing the greatest reduction in symptoms, greatest engagement in treatment and reduced health service usage.

Stargardt disease 1 (STGD1) is the most prevalent form of juvenile macular degeneration. It is caused by a rare, inherited autosomal recessive trait, leading to severe and irreversible blindness by the first or second decade of life. Earlier onset of the disease is related to a rapid vision loss, while patients with a later onset tend to have a better prognosis. This study will enrol up to 10 subjects aged 12-18 years old with a confirmed clinical diagnosis of Stargardt disease type 1 (STGD1). This study will include 2 phases, the phase 1b portion is to determine the optimal dose for phase 2 based on the extent of retinol binding protein 4 (RBP4) reduction after 2 cycles of tinlarebant treatment. The phase 2 portion will evaluate the safety and efficacy of a single daily dose of tinlarebant over a 24-month treatment period.

This study aims define the burden of GI intolerance in patients with kidney failure on dialysis and with kidney transplants, and to understand patients’ experiences of GI intolerance and their perspectives on the management strategies of these symptoms. The hypotheses: 1. GI intolerance is common in patients with kidney failure (transplant candidates) and kidney transplants. 2. Kidney transplant candidates and recipients have different experiences and perspectives of GI symptoms and intolerance. 3. Kidney transplant candidates and recipients have diverse views on the treatment preferences of GI intolerance.

The SERENITY study will look at demographic and lifestyle factors, and procedural information of patients with breast implants and lymphoma to determine risk factors for breast implant associated lymphoma Who is it for? You may be eligible to join this study if you are aged 18 and above, have had breast implant surgery and/or been diagnosed with lymphoma Study details All participants in this study will self nominate to participate by responding to the advertisements. Participants will then complete an eConsent and then a once-time electronic survey. The demographic, lifestyle and procedural information provided/gathered will be used to determine risk factors for developing breast implant associated lymphoma. It is hoped that the information captured by this study will contribute towards planning for a pilot screening program for BIAL in order to support earlier diagnosis and as such better patient outcomes.

This research aims to investigate the effectiveness of Group Clinical Supervision (GSC) within maternity units in twelve Sydney’s public hospitals. The project will explore whether regular access to GCS affects midwives’ perceptions of workplace culture, their intentions to stay in or leave the profession and actual staff retention rates. The level of midwifery burnout will be the primary outcome. The study will include a cluster randomised controlled trial (RCT) with measurement tools that include the Australian Midwifery Workplace Culture (AMWoC) survey tool, the Clinical Supervision Evaluation Questionnaire (CSEQ), the Copenhagen Burnout Inventory (CBI), and workforce data showing staff turnover rates and sick leave from maternity units within the Local Health Districts. The hypotheses are: that regular GCS will improve midwives’ perceptions of their workplace culture and lower their levels of work-related burnout; Midwives with positive perceptions of their workplace culture will be more likely to remain in their profession, and that Maternity units offering regular GCS will have lower levels of midwifery staff attrition than others.

After consuming a meal, blood glucose levels rise which results in the pancreas secreting the hormone insulin. Insulin increases blood flow in skeletal muscle (similar to exercise) and this blood flow effect helps deliver the glucose to the muscle for storage (1, 2). We have recently shown that if someone consumes only glucose in their meal this results in an impairment in muscle blood flow (3). We have recently built on this finding to show that when matched for blood glucose levels, intravenously infused glucose (which by-passes the gut) has the opposite effect and stimulates muscle blood flow (not published). Therefore, our data suggests that a gut-derived factor could be regulating the impaired muscle blood flow observed with orally ingested glucose. The aim of this project is to investigate the effects of one of these gut-hormones called Gastric Inhibitory Polypeptide (GIP) on muscle blood flow. Findings from this study will enhance our knowledge and understanding of blood flow regulation after a meal and has implications in the consumption of high glycemic-index food and drinks. References: 1. Clark MG, Wallis MG, Barrett EJ, Vincent MA, Richards SM, Clerk LH, et al. Blood flow and muscle metabolism: a focus on insulin action. American Journal of Physiology-Endocrinology And Metabolism. 2003;284(2):E241-E58. 2. Keske MA, Dwyer RM, Russell RD, Blackwood SJ, Brown AA, Hu D, et al. Regulation of microvascular flow and metabolism: An overview. Clinical and Experimental Pharmacology and Physiology. 2017;44(1):143-9. 3. Russell RD, Hu D, Greenaway T, Sharman JE, Rattigan S, Richards SM, et al. Oral Glucose Challenge Impairs Skeletal Muscle Microvascular Blood Flow in Healthy People. American Journal of Physiology-Endocrinology and Metabolism. 2018.

Heart disease is the leading cause of death worldwide. The only way to lessen the detrimental effects on the heart during oxygen poor circumstances is to re-introduce oxygen to the cells of the heart (by getting rid of the obstruction responsible for the problem). Re-introduction of blood flow and oxygen to cells that was oxygen poor however also results in damage to the cells. This is known as “reperfusion injury”, the medical world still doesn’t have a treatment option to eliminate reperfusion injury. The aim of this study is to investigate a new treatment option (melatonin) to lessen or eliminate the damage to the heart following reperfusion injury. Although we know that this treatment option is extremely effective in animals (it halved the size of heart attacks in rats), we still don’t have a clear answer to its role in humans. More research is required to determine how melatonin can benefit patients undergoing heart surgery. We thus hypothesize that preoperative, sublingual melatonin will have cardio-protective properties during reperfusion injury, and that the cardio-protection will be as a result of the anti-oxidant and anti-inflammatory effects associated with melatonin supplementation. The degree of cardio-protection, anti-inflammatory and anti-oxidative properties will be assessed by biomarkers (CRP and hsTnT levels found in blood samples). This study will be performed at two centres (Sir Charles Gairdner Hospital and Saint John of God, Subiaco) and is a prospective, randomized, double-blind, placebo-controlled, phase 2 study investigating the oral, preoperative administration of melatonin. Double-blind means that neither you nor your study doctor will know which treatment you are receiving. This research project has specifically been designed this way to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions. However, in the event it is medically necessary your study doctor can find out which treatment you are receiving. The participants will be allocated into three study groups: The control group (receiving placebo with no active ingredients), the low dose melatonin group and the higher dose melatonin group.

This study aims to trial a structured professional judgment approach to the assessment and management of suicide and self-harm risk on a prison mental health unit. The ‘SLIPS’ documentation guidelines will be introduced as an additional resource to aid clinical decision making and safety planning with prisoners at risk of suicide or self-harm. It is hypothesised that the implementation of the approach will lead to a reduction in rates of self-harm behaviour, reported thoughts of self-harm/suicide, and suicide attempts over a 12-month period in a prison mental health unit. The study has an additional component of a qualitative examination of the perceptions and experiences of individuals with a lived experience of self-harm/suicidality in custody as well as staff who provide care and management to them.