ANZCTR search results

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

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30806 results sorted by trial registration date.
  • Randomized Controlled Trial of Duration of Antibiotic Prophylaxis in Head and Neck Surgery with Free Flap Reconstruction, HEDAX Trial

    Study Purpose: The purpose of this research is to establish whether 72 hours of antibiotics is superior to 24 hours of antibiotics in preventing infections of surgical wounds. Who is it for? You may be eligible for this study if you are an adult male or female Undergoing head and neck tumour resection and primary free flap reconstructive surgery for upper aerodigestive tract defects. Study details Participants will be randomly assigned to either 72-hour or 24-hour peri-operation antibiotic prophylaxis groups. Post head and neck operation and free flap reconstructive surgery, they will be monitored from postoperative day 1 to day 30 for incidence of surgical site infection using methods like culture, biochemical tests, radiological imaging, clinical diagnosis and Clavien-Dindo Classification of Surgical complications. It is hoped this information will improve perioperative management so that the best possible outcomes from surgery are achieved for patients having these major procedures.

  • Utility of smartwatches for investigation of the patient with palpitations

    The purpose of the study is to assess the efficacy of smartwatches to investigate patients with palpitations. These are commonly worn by members of the general public, and because they are worn continuously may be able to capture an ECG at the time of palpitations. This may have a benefit over Holter monitors, as these are only worn for a 24-hour period - therefore if the palpitations occur outside the 24-hour monitoring period, patients will not receive a diagnosis.

  • Investigating Sodium Butyrate as Treatment for Anorexia Nervosa

    The primary purpose of this study is to investigate the effects of sodium butyrate in the treatment of anorexia nervosa. We hypothesise that there will be a significant difference in a) improvement of ED symptoms from baseline to end of treatment, and b) increase in BMI from baseline to end of treatment.

  • Promoting haemostasis for central venous access devices: a randomised controlled trial

    When a central venous access device (CVAD – incorporates both centrally and peripherally inserted central catheters) is inserted, it breaches the body’s protective barrier – the skin. Together with the patient’s intrinsic risk factors associated with their illness (e.g., cancer and deranged metabolic function such as in critical illness), this places them at risk of persistent bleeding at the catheter exit site and systemic infections. These complications are highly correlated; bleeding at the insertion site causes dressing disruption, which is associated with an increased risk for central line-associated bloodstream infections (CLABSI). Potassium ferrate haemostatic discs and powder (StatSeal®, Biolife, Sarasota, Florida) contain a strong haemostatic agent which has primarily been used to promote haemostasis post-interventional vascular procedures and interventional cardiology. The haemostatic disc and powder also has the option of being applied at the CVAD skin exit site, however, its role to prevent haemostasis and promote dressing integrity (thereby reducing the risk of infection with longer-dwelling venous access devices), is yet to be explored. To provide further evidence and inform clinical practice, it is important to address this evidence-practice gap and test the safety and efficacy of the potassium ferrate products in promoting haemostasis and preventing dressing disruption for CVADs.

  • Terlipressin for the treatment of refractory hypotension in patients otherwise ready for discharge.

    Persistent hypotension in critically ill patients remains a major barrier to discharging patients from the ICU. In patients with adequate tissue perfusion, an agent that could treat hypotension in order to wean continuous intravenous (IV) vasopressors and therefore promote ICU discharge would be useful. The ideal agent would either be a bolus IV agent or an oral agent. There are several possible etiologies of hypotension in the ICU. The most frequent causes include septic shock, vasoplegia from inflammatory conditions, hypovolemia, adrenal insufficiency, and idiosyncratic reactions from medications. For patients whose reversible causes of hypotension have been addressed but still require vasopressors, terlipressin may prove to be a useful adjunctive medication to successfully increase blood pressure. We hypothesize that terlipressin treatment of refractory hypotension in patients otherwise ready for discharge from the ICU shortens duration of receiving IV vasopressors and ICU length of stay (LOS) without increasing hospital length of stay or putting the patient at risk of being readmitted to an ICU.

  • Prehabilitation Closer to Home Study: Novel Evaluation of a Co-designed Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplantation.

    This study aims to enhance the efficacy and acceptability of a Pre-habilitation Exercise service for Haematological Cancer Patients Preparing for Bone Marrow Transplant at The Peter MacCallum Cancer Centre (Peter Mac). The Prehabilitation Exercise service has been established at the Peter Mac for several years. Our research team engaged in a co-design process with former patients and Peter Mac staff to identify priority areas for improvement and design solutions. This research study will implement the co-designed solutions, evaluate them and make additional improvements where necessary. Who is it for? You may be eligible to join this study if you are aged 18 years and over, have been diagnosed with a Haematological Cancer and are awaiting Bone Marrow Transplant at The Peter MacCallum Cancer Centre, and have been referred to the prehabilitation program. Study details All participants will have access to the prehabilitation exercise service as part of standard care. This includes access to an individualised exercise program and supervised exercise sessions delivered either face-to-face or via telehealth. Improvements developed as part of co-design include staff training modules focused on delivering trauma-informed exercise support and delivering engaging online exercise classes, additional printed resources for patients to support uptake of exercise, support for staff to better utilise exisiting exercise prescription software (simple set), and an online education hub. This study will be implemented in two stages: Package 1 will include standard care plus all of the co-designed components, except for the online education hub, while Package 2 will include standard care plus all co-designed components and the online education hub. Package 2 will be implemented 9-12 months after the study commences, after Package 1 completion. Participants will be followed-up within two weeks prior to their bone marrow transplant to assess efficacy and acceptability of each package. The majority of the assessments completed (e.g., 6 minute walk test) are completed as part of standard care. Study specific assessments include questionnaires on intervention acceptability. It is hoped that this research project will lead to an optimised prehabilitation model of care at the Peter Mac, and pave the way for trialling the optimised model of care across multiple health services.

  • Acceptance and Commitment Therapy for Endometriosis (ACTforEndo)

    Endometriosis is a chronic condition in which tissue similar to that lining the uterus grows on other organs, leading to scarring and adhesions and causing pain, menstrual irregularities, and infertility. Impacting 11% of Australian women and those assigned female at birth, endometriosis is under-recognised due to the variability in symptoms, reliance on surgery for diagnosis, and stigma of menstruation. Usual care, comprising of hormone and pain medications, has limited efficacy, is associated with adverse effects, and is discontinued by up to 40% of people. Recognising the inadequacy of the current biomedical healthcare approach to treating endometriosis, there is a need to address the complex biopsychosocial burden of endometriosis. The current project will be a small feasibility pilot trial to explore whether an adapted, online Acceptance and Commitment Therapy intervention is feasible and acceptable for this population. This study will form a part of a larger study (i.e., CoDeEndo, a hybrid type 1 efficacy and implementation randomised controlled trial evaluating a highly novel online multi-modular supportive care program for Australian adults living with endometriosis) for which ethics approval will be sought once this study is near completion.

  • A clinical trial of changes in gut microbiome from eating a newly created nugget for autistic feeding challenges

    This study aims to determine if a new chicken and plant protein nugget can improve an individual’s gut microbiome when it is eaten consistently (i.e., every day for two weeks). The nugget was created specifically for autistic people with feeding challenges or selective eating preferences. It has been modified in response to autistic people’s feedback about pleasant and unpleasant sensory components of foods in a prior study (e.g., the look, taste, or smell of certain foods). We are trying to create a sensory-friendly food for autistic people that can help improve their gut microbiome. The nugget we are developing uses a modified ratio of protein and fibre that we hope will improve gut microbiome. The nugget has been sensory-modified based on feedback from autistic individuals and caregivers with feeding challenges. The created nugget is not a medicine – it is a sensory-modified food product.

  • Clinical trial to evaluate a digital self-management and mental health intervention for young people with asthma and their families

    South Australia (SA) has one of the highest rates of asthma in the world, and SA children have the highest rate of asthma hospitalisations in the entire country. Many 'basics' of good asthma management are not done well: 90% of asthmatics are not using their inhalers correctly (7), 70% do not have an asthma action plan and 55% have poor medication adherence, costing Australian hospitals $239 million in 2015 alone. Over the past nine-years our team of clinicians, researchers, policy makers, asthmatics, carers and key community stakeholders have partnered to co-design asthma self-management education smartphone application prototypes. The result is an artificial intelligence (AI)-based asthma self-management and education app, called Asthma AI+. Now that we have shown acceptability, usability and feasibility of our app, the next step to creating a game-changing asthma tool is to know exactly how well it works. Therefore, the aims of this project are to show improved asthma symptoms, self-efficacy, quality of life, inhaler technique and mental health/wellbeing, with reduced hospital utilisation and health care expenses, when our Asthma AI+ app is compared to the symptom monitoring control app at 12-week follow-up.

  • Long term outcomes of those undergoing lung cancer surgery.

    The purpose of this study is to determine whether exercise capacity and lung function changes after lung cancer resection surgery, and whether there are any predictors for these changes. Who is it for? You may be eligible for this study if you are an adult with lung cancer that is scheduled to undergo lung cancer resection surgery. Study details All participants in this study will undergo their lung resection surgery as part of their standard care. For this study participants will be asked to attend two sessions at an outpatient hospital clinic to undergo physical exercise and lung function testing and complete a scan. This session will take approximately 2.5 hours and will occur within two-four weeks prior to surgery and again 6 months after surgery. The tests undertaken will be lung function testing, walk testing, symptom questionnaires and a ventilation/perfusion SPECT scan. This study hopes to better understand changes in physical capacity and symptoms after lung cancer surgery and whether there are ways to predict those changes.

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