ANZCTR search results

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

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33655 results sorted by trial registration date.
  • Single Troponin Accelerated Triage of Chest Pain (STAT-Chest Pain) Study: Assessment of the safety and efficacy of an innovative pathway used to triage patients presenting to the Emergency Department with chest pain.

    Acute chest pain is one of the commonest causes of presentation to Emergency Departments (EDs) locally (~7.5% of all attendances to Royal Perth Hospital ED in 2015), nationally and worldwide. The majority (>75%) of these individuals are at low risk of serious complications, with only a small proportion ultimately diagnosed with an acute coronary syndrome (ACS) or other major pathology. The consequences of misdiagnosis are, however, potentially catastrophic. Thus, considerable time and resources are expended to ensure the accurate triage of such patients. Recent data from Shah et al suggests that patients with very low levels of high sensitivity troponin (hs-cTn; a very sensitive and specific blood marker of cardiac injury) on arrival to ED (the majority of all those with presenting with chest pain) are at extremely low risk and could be safely and quickly discharged. They found that of all patients presenting with suspected acute coronary syndromes, 61% had a high sensitivity troponin I of <5 ng/L which had a negative predictive value of 99.6% (95% CI 99.3-99.8) for index myocardial infarction and subsequent myocardial infarction or cardiac death at 30 days. If their serum troponin measurement was taken more than 2 hours after the onset of symptoms then this increased the negative predictive value to 99.8% (95% CI 99.6-100%). Based on this research and current best practice, our group has developed a rapid assessment “single troponin” chest pain pathway that will be introduced at Royal Perth Hospital in early 2018. Using a pre/post cohort study design we will observe the efficacy and safety of this innovative pathway, which offers the most accelerated triage of patients with chest pain currently available, and compare it with the current National Heart Foundation of Australia / Cardiac Society of Australia and New Zealand Guidelines based “Suspected ACS Pathway” which represents current best practice. We hypothesise that using a combination of hs-cTnI levels, careful clinical assessment, objective risk scores and structured, evidence-based, early follow up and investigation will greatly reduce the length of stay for low risk patients without any increase in adverse outcomes. If this proves correct this novel pathway will result in considerable efficiencies and cost savings that can be easily replicated in other hospitals.

  • On-line cooking tips for Sleevers

    We previously recruited 506 adults (mean age 38.8 ± 11.8 years; 18% male) who completed a nutrition questionnaire. Included were individuals with different classes of obesity and past weight loss surgery (11%, n=55). The relationship between demographic characteristics, nutrition knowledge, and diet quality were explored. Those with obesity (BMI >30 kg.m-2) had lower levels of nutrition knowledge and those with a BMI >40 kg.m-2 had the lowest diet quality of the BMI groups studied. The lowest diet quality was reported for individuals with past weight loss surgery. Our findings provide evidence that individuals who have undergone weight loss surgery should be targeted for nutrition interventions aimed at assisting in the adoption of higher quality diets. This study aims to evaluate cooking skills and diet quality of individuals who previously had a Sleeve Gastrectomy (at least 12 months ago) using a cross-sectional questionnaire. In addition, to conducting an on-line intervention that encourages cooking from fresh and basic ingredients delivered via a Closed Facebook group. The intervention will consist of healthy cooking tips and recipes specially developed for individuals 12 months post Sleeve Gastrectomy, delivered over 10 weeks.

  • Effects of Sodium Glucose Co-Transpoter-2 (SGLT-2) in diabetics with heart failure

    Background: Patients with type 2 diabetes mellitus area at a higher risk of developing heart failure and a significant number of patients with established heart failure are receiving treatment for type 2 diabetes mellitus. The EMPA-REG OUTCOME study concluded that the inclusion of empagliflozin in the treatment received by patients with a high risk for cardiovascular events reduced the rate of primary adverse cardiovascular outcomes and mortality. Aim: The aim of this study is to test the hypothesis that treatment with sodium-glucose co-transporter 2(SGLT-2) inhibitors will decrease the risk, progression and severity of heart failure and also if there is any benefit in the quality of life in these patients following the addition of a SGLT-2 inhibitor as part of standard medical care. Methods: Participants will be recruited from the diabetes clinics at Box Hill and Maroondah Hospitals. These patients will have been identified by their treating physicians as suitable for SGLT-2 inhibitors. The SGLT-2 inhibitors (dapaglifozin or ertuglifozin) will be started in the course of normal clinical practice and according to existing clinical guidelines. The SGLT-2 inhibitor will be added to additional therapy or substituted for additional therapy at the discretion of the treating physician. Baseline blood tests and a Living with Heart failure questionnaire will be completed by the patients. Treatment will be monitored and further changes to therapy, the addition of other agents or the discontinuation of other agents, including SGLT-2 inhibitors, will also be at the discretion of the treating physician. Audit information will be collected prospectively but no information will be collected that is not a normal part of clinical practice in patients with heart failure. Recruitment of the participants will be by the registrars/consultants from the diabetes clinics after a thorough discussion about the safety of SGLT2 inhibitors and with full consent by the patient.

  • Comprehensive geriatric assessment and interventions in older lung cancer patients

    This study is assessing the effects of a comprehensive geriatric assessment on health-related quality of life Who is it for? You may be eligible for this study if you are aged over 65 and have a new diagnosis of non-small cell lung cancer (NSCLC) Study details Participants will be randomised (by chance) into two groups. One group will receive the standard oncology care, including blood tests and questionnaire. The other group will recieve standard care as well as a Comprehensive Geriatric Assesment (CGA). CGA refers to the multi-disciplinary assessment of an older patients’ physical function, cognition, mood, other health problems, medication use and social situation, followed by the implementation of an individualised management plan aimed at improving any identified impairments or vulnerabilities. The assessments used and interventions prescribed are all frequently used in common medical, geriatric, practice and as such, are not expected to pose any significant risks or safety concerns. It is hoped this study will demonstrate the utility of the CGA model which may contribute to its implementation in standard practice.

  • Subcutaneous Sumatriptan for Treatment of Post-Operative Neurosurgical Pain

    Craniotomy is one of the common surgeries performed in the modern day and age with brain tumour being the seventh commonest diagnosed cancer in the world. There are multiple other surgical conditions being amenable to craniotomy: Resection of brain tumours and arteriovenous malformations, clipping of brain aneurysms and microvascular decompression for trigeminal neuralgia just to mention a few. Post-craniotomy pain is often under-treated and under-estimated. Both acute and chronic post craniotomy headaches have been found to be common and significant clinical phenomena. In cross-sectional studies of the immediate post-operative pain levels, post craniotomy pain incidence is at 60 percent, more common than generally assumed. Post-operative pain is a common factor in delayed mobilization, lengthened hospital stay, development of anxiety and depression as well as development of chronic pain. Opioids are still the mainstay of post-operative craniotomy pain management. However effective opioid analgesia administration for the purposes of pain relief can precipitate decreased respiration and hypercarbia. We plan to recruit a total of 136 patients in this parallel arm double- blind trial in order to test our hypothesis that patients receiving subcutaneous sumatriptan will have improved analgesia control and recovery scores post-operatively. We will follow up the patients at 30 days to assess these outcomes at the thirty day mark.

  • Emergency Nurse Practitioners use of Point of Care Ultrasound as a diagnostic tool for adult patients with skin and soft tissue infections.

    The research proposed will study the use of Point of Care Ultrasound (PoCUS) to differentiate the diagnosis of skin and soft tissue infections (SSTI). SSTI are a common emergency department (ED) presentation with a differential diagnosis of cellulitis or abscess and therefore differing treatment strategies. The use of ultrasound as a diagnostic tool to determine the subsequent treatment has emerged as an adjunct to emergency physician practice. Nurse Practitioners (NP) as an integral part of the Nepean ED team are expanding their Scope of Practice (SOP) to include the use of PoCUS. This research will look at the NP’s use of PoCUS in the ED to improve time to a diagnosis and the definitive management plan of patients with SSTI. The study will be undertaken using a pre and post intervention design with the intervention being Nurse Practitioners accreditation in the use of PoCUS.

  • Randomised controlled trial comparing the diagnostic yield of initial forceps biopsy vs brushings in Radial Guide Sheath Endobronchial Ultrasound lung biopsy

    Radial guide sheath endobronchial ultrasound (EBUS) is one of the bronchoscopic modalities commonly used for obtaining lung biopsies. This technique utilises both biopsy forceps and brushings to obtain tissue samples. The main objective of this study is to determine whether the sequence of sampling in this procedure affect the diagnostic yield. Who is it for? You may be eligible for this study if you are booked for a radial guide sheath endobronchial ultrasound (EBUS) at Sunshine Coast University Hospital. Study details All participants will be biopsied with both types of sampling methods in a randomised order. The samples obtained will be analysed as per the usual practice. There are no additional tests or assessments for the participants other than what is involved in the usual clinical care. It is hoped this study will provide evidence to guide the optimal sequence of sampling during this lung biopsy procedures.

  • AUTOMATIC: Adaptive Trial of Messaging to Improve Immunisation Coverage

    We aim to conduct randomised multi-arm Bayesian adaptive trial of SMS reminders to determine whether personalised provider-initiated SMS reminders are effective for improving the timeliness of routine vaccination among Australian children. Parents will be enrolled across multiple SmartVax GP clinics and community-based providers in Western Australia.

  • Safely Preventing Errors and Complications in children due to Inappropriate Allergy Labelling by undergoing antibiotic allergy testing in order to confirm or de-label the antibiotic allergy label.

    A fifth of Australian hospital patients self-report an allergy to antibiotics (“antibiotic allergy label”, AAL) which interferes with their optimal clinical care. There is strong evidence that unverified antibiotic allergy labelling is a substantial and growing public health problem resulting in: • Significant adverse patient outcomes • Increased health economic burden • Suboptimal choice of antibiotic, leading to the overuse of broad spectrum antibiotics and the emergence of microbial antibiotic resistance. International studies suggest that the majority (>90%) of subjects with AAL can safely use antibiotics without restrictions following a clinical assessment (“de-labelling”). Thus, unverified AAL is mostly inaccurate and its associated negative consequences are potentially avoidable. There is currently no effective clinical strategy developed that addresses the high national incidence of AAL in Australia. This study aims to develop a new model of care for paediatric patients with current AAL and to improve management of antibiotic therapy in our hospitals and community. A large randomised prospective study design allows for the analysis of key clinical outcomes for all study participants, with regards to details about GP and hospital visits, infection history, subsequent antibiotics usage and mortality, and compares patients which have been actively de-labelled against those receiving current standard care. This project will also calculate the true health economic cost impact of de-labelling patients at a population level, compared to standard clinical care. We hypothesise that a systematic approach to antibiotic allergy de-labelling patients with AAL will lead to a national improvement in clinical care characterised by both better long-term health outcomes and cost savings to the health budget.

  • miniaturised-percutaneous nephrolithotomy (PCNL) versus flexible ureteropyeloscopy for treating kidney stone disease

    LAY SUMMARY Mini-percutanoeus nephrolithotomy (mini-PCNL) and flexible ureteropyeloscopy are commonly used techniques for treating ureteral and renal stones. Both treatment options are invasive and are associated with complications. There are only a few studies that compare these two treatment modalities. Both modalities are associated with reasonable postoperative stone free rates with minimal complications. Immediate stone free rate is higher with mini-PCNL but comparable in both modalities at 1 month. Pyeloscopy is associated with favourable pain scores and lower haemoglobin drop. We aim to compare both techniques to definitively investigate whether one modality is superior than the other. HYPOTHESIS Few prospective randomised controlled trials have compared mini-PCNL and flexible ureteropyeloscopy for treating renal and proximal ureteral stones.Furthermore, no specific guideline is available regarding the optimal surgical management of renal stones and proximal ureteral stones. We hypothesise that one modality is associated with a greater stone free rate and lower complication rate compared to the other modality for managing nephrolithiasis STUDY AIMS: To compare stone free rate and surgical parameters between flexible ureteropyeloscopy mini-PCNL and RIRS in the management of renal stones and proximal ureteral stones >5 mm in a single session. OUTCOME MEASURES The primary end-point in this study is stone free rate (SFR) in a single session. Before a 3-month follow-up visit, all patients will undergo a low-dose non-contrast CT scan to assess for the presence of residual stone. Stone free status is defined as no residual stones or stones within 3 months postoperatively. The secondary outcomes are intraoperative and postoperative parameters such as operation time, hemoglobin drop, analgesic requirement, hospital stay, and complications. Complications will be evaluated according to the Clavien classification of surgical complications. We have published a systematic review and meta-analysis as part of the background information and research to this randomized controlled trial and have attached it to our application: World J Urol. 2018 Feb 16. doi: 10.1007/s00345-018-2230-x. MINIATURISED PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROPYELOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS COMPARING CLINICAL EFFICACY AND SAFETY PROFILE. Davis NF1, Quinlan MR2, Poyet C2, Lawrentschuk N2, Bolton DM2, Webb D2, Jack GS2. Our systematic review and meta-analysis provides a detailed and accurate comparative analysis on mini-PCNL and FURS. We found that modifications and advancements in equipment design will continue to improve the performance of both techniques. The continuing evolution of both urological technologies, should facilitate high levels clinical efficacy while maintaining high safety profiles.

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