ANZCTR search results

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

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32120 results sorted by trial registration date.
  • SOFARI Clinical Outcomes Registry

    The aim of this protocol is to design and implement a clinical quality orthopaedic registry for patients presenting to Drs Michael Symes and Andrew Wines (orthopaedic surgeons) with foot and ankle pathologies. The purpose of the registry is to report patient outcomes after treatment through a retrospective and prospective, consecutive observational cohort study design. This clinical registry will collate and store patient demographic, treatment and clinical data as well as patient outcomes collected routinely as part of the standard clinical pathway for foot and ankle pathology treatments. Outcomes will include clinical outcomes, patient reported outcomes and rates of adverse events following treatment. Recruitment will include all patients presenting with foot and ankle pathology to the principal investigators (Drs Michael Symes and Andrew Wines) at their clinical practices. Patients will be presented with a Participant Information Sheet to inform them of the nature of the registry and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-out approach. Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and pathology. Data collection will be completed routinely at the consulting rooms for the principal investigators. Patients will in addition be requested to complete a set of questionnaires (EQ-5D-5L, Foot and Ankle Outcome Score, FAOS) to enable evaluation of patient reported outcomes as part of their baseline and post- treatment follow up. The clinical outcomes of individual patients will be monitored for up to 5 years.

  • Can adding brain stimulation to strength training improve outcomes in adults with cerebral palsy?

    Individuals with spastic hemiplegic cerebral palsy (SH-CP) face a decrease in functional ability between 10 and 35 years of age, limiting health and quality of life. Interventions that reduce this decline are critical. Though loss of strength has been linked to functional decline in SH-CP, strength training (ST) programs have proven ineffective in improving neuromuscular function and are limited by relatively small strength gains. Strength gains may be slower in SH-CP as a result of alterations in the balance between excitation and inhibition in the primary motor cortex of the brain. The research proposed here will explore this issue using functional near-infrared spectroscopy (fNIRS) to measure brain activity during strength tasks, and to evaluate possible adaptions due to strength training. It will determine the impact of anodal transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, on the observed pattern of neural activity and subsequently, determine whether anodal tDCS, prior to ST, leads to faster and larger strength gains in CP. This research has the potential to improve ST outcomes in SH-CP and lead to increased understanding of the adaptions of the brain in response to anodal tDCS and exercise in SH-CP.

  • An evaluation of patient outcomes from an innovative clinic delivering care in bronchiectasis in a regional centre

    The primary purpose of this study is to evaluate if an innovative bronchiectasis clinic can improve patient outcomes, including quality of life in a regional area. This study will test the hypothesis that the delivery of targeted interventions by a bronchiectasis outpatient clinic will improve quality of life, healthcare utilisation, exacerbation frequency, clinic uptake and attendance and pulmonary rehabilitation attendance.

  • Community supported end of life care

    The project aims to develop, implement and evaluate a model of community volunteer, identified as a Compassionate Community Connector, who can enhance patient, carer and family end of life experiences and reduce the need for patients to be admitted to hospital. This is a partnership between the community and the palliative care service in the South West of Western Australia within the WA Country Health Service (WACHS), aiming to improve the capacity of the service to provide the full aspects of palliative care, including the physical, psychosocial and existential care. It is expected that, by the end of the project, the community will have a sustainable pool of trained and experienced people who can work with the palliative care services to cover the social and practical needs of dying people and reduce the need for hospital admissions. This approach seeks to map and mobilise people’s personal networks of care, through enlisting Caring Helpers (community volunteers) and facilitate access to formal services where necessary. Each Connector will support individuals with advanced illness and their carer/family/social network in the 12 months prior to an expected death. The aim is to train up to 10 Connectors to work with at least 30 families over a 12 week period initially, with a minimum of six contact events, to identify their social and practical needs and help meet them. Sentence for the public: The project aims to assist dying people and their families with their practical and social needs so that patients do not need to be admitted to hospital for these reasons.

  • Acupuncture for Cancer Related Pain

  • Early versus late parenteral nutrition in term and late preterm infants: A Randomized Controlled Trial

    During periods of acute illness in term (= 37 weeks’ gestation) and late preterm infants (between 34 to 37 weeks’ gestation), provision of sufficient enteral nutrition is unachievable, which necessitates the use of parenteral nutrition (PN). PN involves the administration of glucose, amino acids, lipids and various micronutrients. More than 200 babies receive PN in the Neonatal Intensive Care Unit (NICU) at Perth Children’s Hospital (PCH) each year, accounting for up to 1400 PNs annually. In very preterm infants (< 32 weeks’ gestation), nutrition has been extensively researched and hence there is adequate evidence recommending early commencement of PN. However, there is a lack of evidence regarding the optimal time to commence PN therapy in term and late preterm infants. Hence, there are no clinical guidelines for this population. Moreover, nutritional reserve, requirements and morbidity of very preterm infants are different to that of term and late preterm infants. Therefore, it is inappropriate to extrapolate the nutritional recommendations of very preterm infants to term and late preterm infants. The potential benefits of early amino acids include the prevention of catabolism, reduction in hypoglycaemia, improved growth and neurodevelopmental outcomes. Potential harms associated with early amino acids include hyperammonaemia, azotaemia, and metabolic acidosis. The potential benefits of early lipids include the prevention of essential fatty acid (EFA) deficiency, improve nutrition, increase long chain polyunsaturated fatty acids (LCPUFA) and improved neurodevelopmental outcomes. Potential harms associated with early lipids include increased risk of sepsis, worsening of pulmonary hypertension and respiratory function. Therefore, we plan to conduct a randomised controlled trial (RCT) that evaluates the benefits and risks of early versus late PN in term and late preterm infants by comparing relevant biochemical and clinical outcomes. We will also conduct a cost analysis of early versus late PN from a Western Australian (WA) public hospital perspective.

  • Investigating the efficacy of a brief psychotherapeutic intervention in reducing post-event rumination in individuals with Social Anxiety Disorder.

    Post-event rumination has been identified as an important maintaining factor in Social Anxiety Disorder (SAD), and is associated with increased symptom severity and slower responses to treatment. However, little research has been conducted in this area and the current gold standard treatments for SAD do not directly address post-event rumination. This project aims to investigate the effectiveness of a brief psychotherapeutic intervention in reducing levels of post-event rumination in a clinical sample of individuals with SAD. It will involve two conditions: a treatment condition (who receive the brief intervention) and a control (no treatment) condition. Post-event rumination levels for both conditions will be measured in relation to a speech task. It is hypothesised that those who receive the brief intervention will display lower levels of post-event rumination than those who receive no treatment. Following treatment, those in the control condition will return for a qualitative interview, to gather information about the content and nature of their rumination.

  • The hospital costs associated with postoperative complications following small bowel resection surgery

    The purpose of this study is to determine the costs associated with post-operative complications of those undergoing a small bowel resection. Accurately defining the costs of complications allows institutions to make more informed decisions as to what areas comprise a significant cost percentage, and then implement strategies to mitigate this. This study is conducted using a review of medical records, and no patient contact is required. Who is it for? This is a retrospective study evaluating the costs of complications of adult patients who underwent a small bowel resection at the Austin Hospital between January 2013 and June 2018. Study details The aim of this study is to outline the health costs of postoperative complications in patients who undergo small bowel resection surgery. We consider the incidence, type and severity of these complications and expand on the surgical method used in relation to small bowel resection. Further, we highlight the importance of evaluating the components of healthcare cost profiles relevant to patients undergoing small bowel resection. We hypothesise that patients who suffer complications would incur greater costs as compared to patients who did not have a complication. We also hypothesised that as the complication severity increased, there would also be an increase in costs. It is hoped that this study will outline the costs of postoperative complications in patients who undergo small bowel resection surgery, and highlight the importance of evaluating the components of healthcare cost profiles relevant to patients undergoing small bowel resection.

  • Do bisphosphonate tablets improve bone health in patients on dialysis

    We hypothesise that in patients on dialysis, with normal or elevated bone turnover, the use of bisphosphonates will improve some or all of BMD, the trabecular bone score (indicating changes to bone microarchitectural parameters), cortical parameters and the buckling ratio assessed by hip structural analysis, and 3D-Shaper hip parameters that independently assess cancellous and cortical compartments from DXA images. If improvements in these parameters are seen with bisphosphonates, a larger study with fracture outcomes is proposed

  • Nasal solgel therapy performance in post operative sinus surgery patients

    Chronic rhinosinusitis (CRS) is a heterogeneous, multifactorial disease defined by sinonasal inflammation persisting more than 12 weeks. According to the Australian National Health Survey, in 2007-2008, 9.2% of the Australian population suffer from CRS. Along with sinonasal symptoms, patients frequently suffer with low mood, poor sleep and fatigue leading to significant direct and indirect costs to the health system. Despite the prevalence of the condition in the community and the burden both physically and financially, there is an ongoing search for an efficient and practical method to deliver ongoing treatment. The recent International Consensus Statement on the treatment of CRS include nasal saline irrigation and intranasal corticosteroid sprays/drops with the addition of a short course of oral corticosteroids for the CRS with nasal polyps (CRSwNP) subgroup. Topical therapy offers the benefits of high local concentrations without the systemic side effects, however in unoperated sinuses, delivery to the sinus mucosa is limited and less than 2% of the irrigated volume reaches the sinuses. Endoscopic sinus surgery (ESS) is essential to allow topical treatment to effectively reach the sinus cavities and is the treatment of choice in patients who fail to respond to appropriate medical therapy (AMT). The intention of ESS is to restore natural sinus ventilation and drainage pathways, relieve nasal obstruction with the preservation of mucosa, and ultimately allow CRS treatment to be de-escalated from systemic to topical treatments for long-term management. Topical steroids are an integral component of postoperative care in ESS. There is high-level evidence supporting their use, which has been shown to significantly improve patient’s self-reported symptoms and endoscopic scores at 6 & 12 months. In the clinical setting, steroids are mixed into high volume washes for delivery. Unfortunately, these devices have short mucosal contact time and require daily use. Ideal drug preparation should be delivered in a manner to optimise mucosal contact time with steady absorption & minimal wastage. Mucoadhesive, thermoresponsive in situ gelling systems (solgels) pose a potential vector for drug delivery. These polymer-based gels can be formulated to rapidly transform in situ from a liquid to gel once at sinonasal temperature and slowly release a drug to the target tissue. Recently, these soluble gels have been analysed ex-vivo in human nasal tissue and demonstrated prolonged mucosal contact time and sustained release of dexamethasone. Establishing the viability of these gels in-vivo opens an innovative method for drug delivery to the sinonasal mucosa with potential to treat a broad range of sinus conditions. This aim of this trial is to assess the use of solgels as a vector to deliver steroid to surgically opened sinus cavities. Assessment of delivery to sinuses, residence time & local side effects will be the primary areas of interest.

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