ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30927 results sorted by trial registration date.
  • 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

  • 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.

  • Diabetes Alliance: Adult Diabetes Integrated Care Delivered in General Practice

    The Diabetes Alliance intervention recognises that general practitioners (GPs) and practice nurses are often the first point of care, therefore best placed to diagnose and provide ongoing care to people with diabetes. For those living in metropolitan areas, diabetes care would typically include access to specialist consultations and a diabetes management team with multidisciplinary expertise to minimise long-term morbidity. Diabetes Alliance works in regional, rural, and remote areas to integrate hospital specialists with multidisciplinary expertise, with GP practices and GPs to enhance primary care capacity and capability. The aim is to share skills, knowledge, and resources to enhance diabetes care through three core activities: case conferencing, delivered directly to a small proportion of adults with diabetes; practice-level performance monitoring; and education and training sessions. The hypothesis is that enhanced capacity and capabilities will translate to clinical improvements in all patients with diabetes seen in the general practices who have received the Diabetes Alliance intervention.

  • Colchicine Atherosclerotic Plaque (CAP) – Biomarker and Imaging Sub-study (of the COLCARDIO-ACS and CASPER Studies)

    This imaging sub-study will use FDG-PET/CT & CTA angiography (Carotid/ Arotic) to answer the question of if Colchicine administration will reduce vascular inflammation and improve plaque stability. Selected sites participating in the COLCARDIO-ACS (ACTRN12616000400460) and CASPER trials (ACTRN12621001408875) trials will be participating in this CAP sub-study. A sub-set of these sites will collect additional research blood for 40 participants.

  • Effect of an Avatar App on Knowledge and Behaviour after Heart Attack

    Avatar-delivered education via an app is a novel approach to assist health care workers provide good quality education to adults after heart attack during the hospital admission, and may be more suitable than traditional written materials for adults with poor literacy. The app contains six modules based on the Heart Foundation’s Six Steps to Cardiac Recovery. This study will compare the app to usual care in a randomised, controlled trial. Study outcomes will include change in knowledge, attitude and beliefs around heart disease, change in quality of life, health care utilisation, response to heart attack symptoms and impact on heart disease risk factors.

  • Maintaining Remission of Ulcerative Colitis with Faecal Microbiota Transplantation: the MR-UC-FMT Trial

    Maintenance of Remission for Ulcerative Colitis with Faecal Microbiota Transplantation; the MR-UC-FMT trial is prospective clinical trial designed to determine the dosing interval of Faecal Microbiota Transplantation administered by enema with a view to maintain remission following induction with FMT and prednisolone. The study recruits patients with mild to moderate Ulcerative Colitis and enrols them into two phases of the trial. The first phase involves an 8 week course of prednisolone with a Faecal Microbiota Transplantation given via colonosopy at week 5 with a view to induce remission or adequate clinical response. Those patients who respond to treatment will be openly randomised to receive FMT via clinician administered enema every 4 or 8 weeks for a further 40 weeks (total 52 weeks). The study aims to test the hypothesis that: -FMT given more frequently via enema is more likely to result in the patient's microbiome becoming more similar to the FMT than the patient's baseline microbiome. -The therapeutic effect of FMT is that the bacteria in the patient's colon become the same as those in the transplant material. -The therapeutic effect of FMT is to improve the diversity of bacteria in the patient's colon -FMT is more effective if given with prednisolone for induction of remission. -FMT given more frequently improves outcomes including time to flare, weeks in flare and clinical or endoscopic remission at 28 and 52 weeks.

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