ANZCTR search results

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

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31134 results sorted by trial registration date.
  • Personalising immunosuppression in liver transplantation

    We propose a prospective cohort study of 210 adult liver transplant recipients followed up for 12-months, to determine the utility of combining two novel blood tests - quantiferon monitor and donor-specific cell free DNA (QFMdscfDNA) - in monitoring and managing immunosuppression post liver transplantation. Our primary hypothesis is that the QFM-dscfDNA tests can be used to accurately diagnose the occurrence of rejection or infective complications after liver transplantation. The secondary hypotheses are that the QFM-dscfDNA tests can be used to predict acute rejection or infective complications, monitor treatment responses and improve healthcare resource utilisation.

  • Dietary periodisation to support training outcomes in elite distance athletes (Supernova 1)

    There is controversy both in lay and scientific circles regarding the best dietary approach to promote maximum performance gains during training for endurance sports. The current study will utilise the recognised research skills of AIS Sports Nutrition and the AIS Canberra Campus environment to implement careful dietary control to compare the results of the three different dietary approaches to the same intensive and periodised training program in elite distance athletes: 1. High carbohydrate (CHO) availability for all training sessions 2. High-fat low CHO (LCHF) 3. Periodised diet involving a careful integration of sessions with high and low CHO availability We will examine the effect of a 3 week training block with these different approaches to dietary support on indices of health, adaptation of the metabolic response to exercise and performance in a cohort of highly competitive race walkers, undertaken within 2 training/research camps.

  • Improving Quality of Care Through Detection of Complexity Amongst Older People in a Community Setting: Pragmatic Randomised Controlled Trial Protocol.

    ImPaCt is a study to trial the PCI within the community nursing service to enhance detection of the patient complexity in our service. The primary objective is to explore whether adding the PCI to usual assessment process could enhance detection of complexity of patients. The secondary objective is to explore whether using the PCI derived patient complexity could facilitate appropriate resource allocation; this resource being the time allocated to providing clinical care to the complex patient. The study will also explore issues around feasibility and acceptability of the PCI in the community nursing service.It is anticipated that the study will explore if the PCI is a suitable tool to enhance the detection of complexity and support resource and time allocation for patient. This study has the potential to provide recommendations to the developer for modifications for Australian use and inform a larger multi-site trial.

  • A study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain participants on long term opioid treatments

    There is some evidence that cannabinoids may enable patients to reduce their opioid medication whilst maintaining adequate analgesia - known as opioid sparing. If so, cannabinoids could prove effective in reducing drop-out rates in opioid dose taper regimen, assisting patients with poorly managed pain. This protocol is a preliminary dose escalation pharmacokinetic study which will evaluate the safety and tolerability of a cannabinoid (THC:CBD) oil formulation following a single dose and following repeated dosing in patients with chronic non-cancer pain. The data from this pharmacokinetic study will inform a subsequent trial which will assess the impact of oral CBD/THC combination oil on patient ability to tolerate a stepped opioid tapering protocol at a rate of 10% per week over 10 weeks.

  • A research study to see if infrared light applied via the nostril is safe and will help reduce symptoms for people with overactive bladder.

    Overactive bladder is a term describing the clinical problem of urinary urgency +/-urgency incontinence. It is a bothersome condition that occurs equally in men and women. OAB places a burden on both the individual and the healthcare system. It is associated with reduced quality of life, increased risk of falls, high healthcare utilisation, personal cost and lower work productivity. This research study is the second part of a two-part study that aims to establish whether intervention with Near Infrared Red Light therapy delivered via a nasal prong can help to reduce the symptoms of overactive bladder. It is hoped that this research will lead to a more effective and standardised treatment plan for people with overactive bladder. The research intervention (Near Infrared Light) has successfully been used for other conditions where people are in pain.

  • A single centre prospective study on the safety and efficacy of per oral endoscopic myotomy (POEM) in the endoscopic management of achalasia and other oesophageal motility disorder

    The purpose of this study is to assess the safety and efficacy of an endoscopic procedure called “POEM” (Per Oral Endoscopic Myotomy). The POEM procedure is a novel endoscopic treatment used for motility disorders of the oesophagus. POEM is a minimally-invasive endoscopic therapy with similar clinical responses to current surgical treatments, and shown to have shorter recovery time and less post-operative pain. Who is it for? You may be eligible for this study if you are 18 years or older and have been diagnosed with the oesophageal motility disorder “Achalasia”. Study Details All participants will undergo the POEM procedure; performed with deep sedation administered by an anaesthetist (you are not likely to feel the entire process). The procedure itself involves an endoscope entering through your mouth into the oesophagus, and then a special tiny knife in the endoscope is used to cut away specific muscle fibers in the oesophagus. When this is done the endoscope will come back up through the mouth. You will be asked to return to the Gastroenterology clinic at 3 months, 6 months, 12 months, and 24 months following your procedure for follow-up visits. Because POEM has not been formally assessed in South Australia, we are interested to see how well this procedure compares to the current established treatments. We hope this research will help provide information on the safety and usefulness of POEM as a potential replacement for current treatments options for achalasia and other motility disorders of the oesophagus.

  • FeBRILe3 Project - Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months old.

    The FeBRILe3 project aims to look at the safety of earlier discharge home for well-looking, low-risk infants admitted to hospital with fever. It will monitor for unplanned hospital presentations or readmissions and other complications to show the safety and impact of this intervention in the WA population. We will collect information about all infants under 3 months old admitted to hospital with fever to provide further information about their signs and symptoms, investigation results, and diagnoses. We will also ask additional information from care-givers to understand their experience of during and after their hospital stay. We expect this information will help guide further management strategies to improve patient care and the hospital experience.

  • The Human Touch: The Influence of Human Support on Adherence to, and Outcomes of, an Online, Lifestyle-based Mental Health Intervention

    Mental health is in global jeopardy and devising efficacious promotive, preventative and curative solutions is paramount. In a progressively digital culture, program designers are replacing face-to-face (F2F) intervention delivery in favour of increasingly sophisticated online and mobile options. The paradigm shift overcomes numerous obstacles of inaccessibility, yet, online delivery poses unique challenges regarding the interrelated factors of adherence and human support. While human interaction is an intrinsic element of F2F interventions, program designers must evaluate how to add the human support component (e.g. dosage, type) back in to online programs to optimise adherence and outcome measures. This study will explore what influence graded levels of human support have on the outcomes of and adherence to an online, lifestyle-based mental health intervention. Participants will be randomly assigned to three Arms, differentiated by variant levels of human support: Arm 1 – standard online program with no additional human support; Arm 2 – same standard program as Arm 1 with additional personalised SMS support; Arm 3 - same standard program as Arm 1 with additional weekly online group discussion (i.e. videoconference). Measures of mental health and wellbeing will be collected for all participants at pre- and post-intervention and comparisons made between the Arms. Adherence to the intervention will also be compared between the Arms. This study will contribute to an evidence-based rationale for intervention planning, to maximise program efficacy through optimal human support and adherence. The study will also inform the optimal levels of human support when administering online interventions.

  • BREATH STUDY: Short and long-term effects of therapeutic exercise in children with bronchiectasis: a multi-centre randomised controlled trial

    Children with bronchiectasis regularly experience exacerbations of their condition resulting in frequent hospitalisations and decreased of quality of life (QoL). Therapeutic exercise may reduce the incidence of acute exacerbations, which is a key predictor of future lung function decline and morbidity. This study aims to determine if a tailored, 8-week therapeutic exercise program delivered to children aged 6 to 12 years with bronchiectasis prevents acute respiratory exacerbations. The primary hypothesis is that children who undergo the exercise program will have fewer exacerbations over a 12-month period than children who do not receive the intervention.

  • What is the effect of a shared leadership system for maternity emergency teams on team performance ?

    Traditionally during maternity emergencies, it is recommended that a single leader take charge. However, in many critical circumstances there may be too many things for a single leader to do. This project aims to test a system where the leadership tasks can be shared between two leaders to determine if this is superior to a singular leadership model.

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