You can narrow down the results using the filters
-
Effects of a Cold-Shower Therapeutic Intervention on Symptoms Associated with Depression.
The aim of the proposed study is to examine the efficacy of cold-water showers as a potential therapeutic intervention for the reduction of symptoms associated with depression amongst a non-clinical sample. The proposed study will address the question; “Can a cold-water shower intervention, decrease symptoms associated with depression and help to boost well-being”? It is hypothesized that a cold-water shower intervention will reduce symptoms associated with depression. It is additionally hypothesized that a cold-water shower intervention will increase levels of well-being.
-
Investigating the use of biomarkers to predict pregnancy and long term complications in women who develop elevated blood pressure, gestational diabetes, fetal growth restriction or spontaneous preterm labour during pregnancy
Purpose of study: In Australia, up to 1 in 20 women will have a pregnancy impacted by pre-eclampsia, however recent changes to the definition of high blood pressure may assist in finding women most at risk earlier in their pregnancy. This study will explore a new approach to diagnosing pre-eclampsia that could benefit women in the future. Similarly, a third of women are affected by cardio-metabolic conditions during pregnancy such as gestational diabetes (GDM), pregnancy induced hypertension, pre-eclampsia, fetal growth restriction and spontaneous preterm birth. These conditions not only cause significant morbidity during pregnancy but are also associated with increased risk of maternal Type 2 Diabetes and Cardiovascular Disease (CVD) after pregnancy. However, CVD risk prediction tools do not capture these pregnancy-related cardio-metabolic conditions. Younger women and their health professionals have a limited understanding of the risks and screening and prevention are generally lacking. We know that these risks can be reduced by preventative screening (such as early screening for diabetes, abnormal lipid levels or elevated blood pressure) and optimising lifestyle strategies. This study offers an important opportunity to identify and target these women at risk for early intervention and screening. Hypothesis: Biological markers of endothelial, placental, inflammatory and cardiac dysfunction can be used to create an algorithm that can better predict the risk of developing pre-eclampsia, as well as risk of long-term cardiovascular sequelae in patients affected by pregnancy complications. Evidenced by derangement in cardio-metabolic markers following development of these conditions which persists post-delivery. Study design: Prospective observational trial involving two blood collection during pregnancy as well as after delivery. Where possible these blood test would be performed at time of routine pathology collection. Blood test result of patient who develops complication and those who does not is compared to develop an algorithm for prediction and diagnosis of pregnancy complications, as well as evaluate risk of long term cardiovascular complications. This study is observational only and does not interfere with routine antenatal care.
-
A Randomized, Double-blind, Placebo-controlled Phase I Study of Subcutaneous EQ102 Administered in a Single and Multiple Ascending Dose Schedule
This study is a First in Human, randomized, double-blind, placebo-controlled study of subcutaneous EQ102 administered as single (SAD) or multiple (MAD) doses. In Part A (SAD), up to approximately 48 healthy adult men and women will be enrolled and randomized to 6 cohorts (n=8 per cohort) to receive single ascending doses of EQ102 at doses of 50, 100, 200, 500, and up to 1000 mg or placebo. Dosing in each cohort for Part A will commence with two sentinel participants with one of the two sentinels randomized to receive EQ102 and the other randomized to receive placebo. EQ102 will be given in sequential, escalating doses contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). In Part B (MAD), healthy adult volunteers will be enrolled and randomized to 3 cohorts (n=8 per cohort) to receive multiple ascending doses of EQ102 or placebo. In Part B, up to three dose levels will be evaluated in healthy volunteers. The starting dose for Part B will be based on review of safety and PK data from Part A. The decision to escalate between dose levels will be based upon review of all safety and PK data.
-
The Happy Parenting Project: Respectful Approach Classes for Early Parenting
Early childhood is a joyful but often stressful time for parents--mealtimes can be battlefields, leaving the house can be an ordeal, and reasonable requests can result in meltdowns. Parents who regularly feel stressed are more likely to experience poor mental health, including feelings of failure and isolation. In turn, children raised in a stressful environment can have poorer emotional and behavioural development outcomes. Our research aims to investigate a distinctive style of early parenting known as the Respectful Approach and how it may improve stress and other health outcomes in parents and their young children. Originally designed for institutional care in Eastern Europe and introduced to the USA by Madga Gerber, it focuses on developing a cooperative relationship with the child. Parents are guided to treat their infants as capable and independent, with emphasis on sensitive observation and attention to cues. Our preliminary research on the Respectful Approach showed that our parent-child education workshops significantly lowered parents stress levels and increased their parenting confidence. Parents also better understood their children’s capabilities. Going forward, we want to discover whether the Respectful Approach also has benefits for children’s health - particularly stress, behaviour, growth, and development. We want to provide a preventative, evidence-based education program to empower parents to develop cooperative relationships with their young children. We hypothesise this will reduce stress in families and improve child health outcomes.
-
AMBLE Trial: Iron Deficiency Anaemia in Major Cardiac, Abdominal and VascuLar surgery patients and Effect on functional outcomes
Iron deficiency is the commonest nutritional deficiency globally, affecting 2 billion people and is the leading cause of anaemia. Iron deficiency anaemia makes people tired and unwell as well as impacting physical function, it is a WHO top 10 leading cause for disability. Anaemia is common in patients undergoing major surgery and associated with worse patient outcomes and increased post operative mortality. The aim of this trial is to explore the mechanisms of iron deficiency over the perioperative time period in patients undergoing cardiac, abdominal and vascular surgery and the response to intravenous iron therapy that bypasses the normal Hepcidin mediated iron pathways. Secondary aims include to assess the efficacy of intravenous iron and measuring potential effects on patients’ physical recovery. AMBLE will be a prospective, parallel-group, double blinded, randomised, multi-centre trial designed to investigate the effects of intravenous iron therapy on disease progression in cardiac, abdominal, and vascular surgery patients. Two separate groups of patients will be assessed: The Perioperative group of patients included if about to undergo major cardiac, abdominal and vascular surgery to assess the mechanisms of iron deficiency in the perioperative period. The Recovery group of patients included 4 weeks after hospital discharge following major cardiac, abdominal and vascular surgery to assess recovery of physical function and anaemia. The outcomes of this research will generate a better understanding of the mechanism of iron deficiency anaemia in surgical patients as well as how this affects post operative recovery. By better understanding the aetiology of iron metabolism in surgery we can determine what intervention (iron +/- EPO) may improve patient outcomes and the administration timing thereof. As a result, more informed decisions will be made regarding iron supplementation and therapy in these patients.
-
Effect of potassium bicarbonate supplementation on muscle protein synthesis in older women
Previous studies have shown that nutritional supplementation with potassium bicarbonate causes older adults to excrete less nitrogen (protein) in their urine. As a major source of protein in our body is muscle, these previous studies suggest that supplementation with potassium bicarbonate may have a muscle-preserving effect. This study will test whether potassium bicarbonate supplementation improves muscle protein synthesis rates in older women. In addition, we will examine whether potassium bicarbonate has beneficial impacts on markers on bone turnover, as there is also some evidence that potassium bicarbonate supplementation may favourably affect bone health in ageing. To do this we will recruit 20 women aged between 65 and 90 years who will take part in two 21-day study phases. During Phase 1, the participants will be randomly allocated to receive either potassium bicarbonate supplements or placebo supplements. After Phase 1, participants will have a 3-week “wash-out” period during which they do not take any supplements. Following this, participants will complete Phase 2. This study phase will be identical to Phase 1 with the exception that participants will take the alternate study supplement. At the end of each study phase, we will measure the rate of muscle protein synthesis. To do this, participants will consume a dose of deuterated water and trained personnel will collect thigh muscle samples and blood samples from each participant. Participants will also collect 24-h urine samples at the beginning and end of each phase. In the blood and urine samples, we will measure markers of bone health and acid-base status.
-
Evaluation of a national helpline service (ForWhen) to support perinatal and infant mental health
In 2021, Karitane and the Australian Association of Parenting & Child Health (AAPCH) received funding to deliver a new national perinatal and infant mental health (PIMH) program, called ForWhen. The ForWhen program will provide a national comprehensive stepped continuum of care for parents experiencing moderate to severe PIMH concerns, supporting these families to navigate the complex and fragmented PIMH service landscape. ForWhen Navigators will be based in every state and territory at an AAPCH partner site. From 2021-2024, researchers from the Discipline of Psychiatry & Mental Health at UNSW will conduct a formal evaluation of the ForWhen program. This will include a detailed description of service delivery, and an evaluation of clinical outcomes and implementation effectiveness. Specifically, the evaluation will examine whether clients who access the ForWhen program experience improvements in their mental health and wellbeing, are satisfied with the service, and are successfully connected with appropriate mental health treatment.
-
HIP fracture Supplemental Therapy to Enhance Recovery
Every year more than 22,000 Australians break their hip, costing hospitals $579 million and requiring more than 579,000 hospital bed days. Only 24% of patients regain their usual walking capacity after 4 months. Previous research showed patients receiving higher intensity physiotherapy regained their physical capacity more quickly and spent fewer days in hospital than those receiving regular physiotherapy care. In this trial we will test whether the intervention can deliver the same benefits at a range of Australian hospitals. This randomised controlled trial will take place across 8 acute hospitals, recruiting 620 participants. Participants allocated to the intervention group will receive intensive physiotherapy, delivered 3 times/day for 7 days following surgery. Those allocated to usual care will receive what is usually provided at that site. The primary aim is total hospital length of stay. Secondary aims include costing and patient reported outcome measures over 12 months post hip fracture surgery.
-
Noah Medical FRONTIER Study: First Human Use of a New Robotic Electromagnetic Navigation Bronchoscopy with Integrated Tool-In-Lesion-Tomosynthesis (TiLT) Technology (Galaxy System) for Small Peripheral Pulmonary Nodules
Expand description -
Assessing lymphatic drainage of the normal splenic flexure by single-photon emission computerised tomography (SPECT) technology – A feasibility study
This study aims to assess the feasibility and safety of using a novel technique (i.e. radio-nuclide tracer [radioactive dye] that is injected directly into the bowel during a routine colonoscopy) to understand how a specific portion of the colon functions. The aim of the study is to see how the colon situated in the left upper quarter of your abdomen, near the spleen (i.e., splenic flexure) manages to drain its tissue fluid (i.e., lymph). So far, lymphatic drainage of this part of the colon remains incompletely understood. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been scheduled for a standard care colonoscopy (i.e. to investigate the reason for presentation to a surgeon), and are in good general health without a clinically significant medical history. People who have been diagnosed with colon or rectal cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will undergo a standard colonoscopy procedure. As part of this study, participants will have a small volume of a radioactive tracer injected into their colon (large intestine) for additional imaging. The research phase of the colonoscopy and injection is anticipated to take 15 minutes. Within one to two hours after the injection has been made, participants will then be taken to the SPECT-CT scanner to have additional images taken of their bowel. This imaging procedure is anticipated to take one hour. Participants will be able to return home after the SPECT-CT. A study investigator will then contact all participants via phone call at 1 day, 7 days and 30 days after the imaging procedures to check on their health and determine any potential side effects of the injection. It is hoped this research will contribute to our knowledge, insight and understanding of the lymphatic drainage of the healthy (non-cancerous) splenic flexure, using the most practical method available. Having knowledge of lymphatic drainage in healthy splenic flexures, we can then then explore the lymphatic drainage in individuals with cancer in the splenic flexure in future studies. We hope that these future studies will also improve understanding and optimise surgical management of splenic flexure cancers, leading to improved outcomes for these patients.