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The use of Mepolizumab has demonstrated success in the management of eosinophilic asthma. Anecdotal experience with mepolizumab in a well defined group of chronic rhinosinusitis patients with eosinophilic inflammation has been very positive. This study assesses the effect of mepolizumab in nasal polyp eosinophilia, in particular, aiming to demonstrate the effect of mepolizumab treatment of respiratory mucosal eosinophilic inflammation at the tissue level, in addition to the serum eosinophil level. This study aims to assess factors that may contribute to treatment success and failure including tissue histopathology, serum/blood biomarkers including blood eosinophils, assessment of recorded endoscopy and patient reported clinical improvement based on patient reported outcome measures. This study would provide evidence of the direct tissue response to mepolizumab, provide a relationship between tissue and serum levels and might provide prognostic information to responders to therapy.

This study is designed to test the hypothesis that MAP application to the skin using a small number of healthy adult subjects with a well characterised influenza vaccine antigen (A/Singapore/GP1908/2015) results in comparable safety / local skin reaction to conventional intramuscular vaccination. This study represents the first time that polymer MAPs with an active vaccine will be applied to humans. Therefore, this study will assess both systemic and the local reaction to application of the A/Sing MAP delivering a 15 mcg HA intramuscular-equivalent dose with the application of three MAPs, in comparison to uncoated MAPs, intramuscular injection with Afluria Quadrivalent (delivering 15 mcg A/Sing HA) and intramuscular injection with 15 mcg A/Sing HA (as a monovalent antigen). The local skin response will be monitored for up to 60 days. On-site clinic assessments will be performed up to 2 hours post application and at 1, 3, 7, 21 and 60 days (if required) post application. Phone calls will be made at Day 36 and Day 50

The incision for major hepatobiliary surgery is across the right upper quadrant of the abdomen extending up the midline. Due to its size and position this incision can be very painful and affect normal breathing and mobilization. Inadequate control of pain can lead to impairment of ventilatory capacity with subsequent respiratory complications. Regional anaesthesia is often employed to improve pain control. It also has the benefit of reducing the requirement for opioids and therefore reducing opioid side effects, such as nausea, constipation and itch. Transversus abdominis plane (TAP) catheters have been found to be non-inferior to epidural anaesthesia for abdominal surgery. Current standard of practice at our institution is to place a TAP catheter and infuse a slow continuous infusion of local anaesthetic via a volumetric pump at a fixed rate. However, it is not known whether the most effective method of delivering local anaesthetic is via continuous infusion or intermittent bolus. Intermittent bolus has the presumed benefit of volume effect and further spread and therefore may provide better analgesia. We plan to compare timed intermittent boluses of regional anaesthesia (TIBRA) to a slow continuous infusion of local anaesthetic in terms of analgesic efficacy and opioid requirement. From January ’18, all eligible patients undergoing major hepatobiliary surgery will be identified in surgical clinic and invited to participate. The study is anticipated to run for 12 months. Participants will be randomised into either continuous or intermittent bolus group. The participants will not know which group they have been randomised to. Each day they will be visited by a member of the research team and asked to score their level of pain on a numerical rating scale. The total dose of other painkillers required will be documented, and they will be asked about any side effects they may have from these medications.

The primary purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic outcomes with standard beta lactam antibiotics given to patients with febrile neutropenia as a result of intensive chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have been prescribed a course of intensive chemotherapy for acute leukaemia or high-grade lymphoma. Study details This is an observational study, so all participants will undergo the standard care prescribed to them by their treating physician. To assess outcomes, blood samples will be taken at baseline, two samples approximately 24 hours after commencement of antibiotics and at onset of fever, and one urine sample will also be taken 24 hours after onset of fever. Additional information including length of antibiotic use and hospital stay will also be noted. It is hoped that the findings of this trial will aid understanding of the distribution and levels of this class of antibiotics in the body, and their impact on outcomes in patients with febrile neutropenia as a result of intensive chemotherapy.

Ovarian cancer is the second most common gynaecological malignancy and the most common cause of gynaecological cancer death in Australia. The majority of women are diagnosed with advanced disease, where standard treatment includes surgery followed by six cycles of adjuvant platinum-based chemotherapy. The purpose of this research project is to test how safe and effective the combination treatment of durvalumab and tremelimumab in combination with standard chemotherapy is as a treatment for patients with ovarian, fallopian tube or peritoneal cancers. Who is it for? You may be eligible to join this study if you are a female aged 18 years or older with a confirmed diagnosis of stage III or IV high grade serous ovarian, fallopian tube, or peritoneal carcinoma, and a life expectancy of at least 12 weeks. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive [18 weeks/6 cycles] of treatment with Carboplatin, paclitaxel combined with durvalumab and tremelimumab (Du-T-NACT) administered intravenously (i.e. directly into the vein). This will then be followed by maintenance therapy with Durvalumab (every 4 weeks) and Tremelimumab (every 12 weeks) for 36 weeks or until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Durvalumab and tremelimumab are new drugs which are designed to increase the body’s immune response. Participants in the other group will receive [18 weeks/6 cycles] of chemotherapy with Carboplatin and paclitaxel only, followed by an observation period, which involves 4 weekly CA-125 assessments. Participants in both groups may also undergo interval debulking surgery after 3 cycles of treatment, if suitable. All participants will be monitored regularly for up to 12 months post treatment in order to assess clinical response and treatment safety. It is hoped that that durvalumab and tremelimumab will stimulate the immune cells to be able to prevent or slow down cancer growth. The study aims to recruit 75 patients (50 patients to receive adjuvant treatment and 25 to receive neoadjuvant treatment at a 2:1 ratio), across 10 Australian sites over a 2 year recruitment period.

All-polyethylene (AP) tibial components in patients aged greater than 60 years have stable tibial migration patterns and favorable survival rates when compared to identical metal-backed (MB) designs. Tibial component fixation in patients aged less than 60 years was measured with radiostereometric analysis (RSA) and compared to a previous cohort of AP and MB tibial components of identical design in patients aged greater than 60 years. Methods A prospective consecutive study examined tibial component migration in 21 patients aged less than 60 years undergoing a cemented total knee arthroplasty with an AP tibial component by RSA to 24 months. Results were compared to the authors previous series of 21 patients aged greater than 60 years that were randomized to either an AP or MB tibial component. The articulating geometry and stem design of the implants were identical as were the operative technique and post-operative regime Results At 2-years both age groups of patients implanted with an all-polyethylene component had stable migration patterns with no patient having greater than 0.2 degree rotation or 0.5mm maximum total point motion. Five of 11 metal-backed tibial components displayed continued migration between 1 and 2 years. Median internal/external rotation was greater with MB components; 0.15, 0.08, 0.28, AP < 60 years, AP > 60 years, and MB cohorts. Subsidence significantly greater for MB implants; median subsidence 0.17, 0.10, 0.25, AP < 60 years, AP > 60 years, and MB cohorts. Median maximum total point motion was greater for the MB cohort 0.34, 0.33, 0.61mm, AP < 60 years, AP > 60 years, and MB cohorts Conclusions Young patients implanted with an all-polyethylene tibial component had stable tibial migration patterns comparable to older patients with the same all-polyethylene implant. Regardless of age, all-polyethylene tibial components were at least as stable as metal-backed tibial components. The study will continue until 10-years.

The Adjunctive Lithium for Acute Suicidality (ALiAS) Trial is an Australian Rotary Health supported project lead by Professor Gin Malhi at the CADE Lithium Clinic, Royal North Shore Hospital (Sydney, NSW) and The Northside Clinic (Sydney, NSW). With a team of international and local collaborators, researchers will conduct a clinical trial sponsored by the University of Sydney. Lithium is a medication that has been in use for many years for the treatment of mood disorders. It is typically prescribed once a patient is out of hospital, and as such, little is known about whether it can produce specific antisuicidal benefits that can be harnessed more rapidly (e.g. while patients are still in hospital or at other critical times), though early findings are providing some clues. The ALiAS trial will determine whether added lithium treatment can produce early antisuicidal benefits, and whether these benefits can be sustained during the at risk period, which is in hospital and just after discharge. Patients from an inpatient unit and the community will be referred and screened, and suitable patients will be randomly allocated receive five weeks of lithium or placebo treatment, in addition to treatment as usual. Patients and selected researchers will not be aware of whether the patient is receiving lithium or placebo treatment. Patients will be monitored regularly and will be assessed weekly either in hospital or at the CADE Lithium Clinic. The weekly assessment will include a blood test, answering researcher administered questionnaires, completing self-report questionnaires, and a clinical consultation where the patient’s lithium levels will be examined and following week's medication will be prescribed. The primary outcome measure is suicidality, which we expect to reduce more rapidly and to a greater extent over the five weeks in the lithium treated group, in comparison to the placebo treated group.

This cluster randomised controlled trial aims to evaluate the impact of an outcomes based funding model in primary care practice. The model provides targeted practice incentives for patient enrolment with a preferred provider, longer consultations, same day access and structured follow-up after hospitalisation. The impact of the model on quality of care and health service utilisation for patients at increased risk of hospitalisation will be compared to usual care.

There is some evidence that artificial sweeteners are associated with an increased risk of type 2 diabetes and in some studies this risk is greater in normal weight people. Clinical trials have not shown a definite increase in risk but a small study has shown that saccharin increases glucose intolerance in 4 days in half of the people studied. A second study showed that sucralose and AceK increased glucose absorption by 25-30%. We aim to investigate 2 weeks of usual artificial sweetener intake and measure 24 hour glucose levels over 2 weeks in response to normal foods and glucose, insulin and c peptide response to 75g of glucose before and after exposure to the sweetener and the control drink. We will examine normal weight and overweight men and women.

Our study will be the first to characterize the gut microbiome in Huntington's disease (HD). Despite strong evidence in animal model studies, highlighting the interplay between the gut microbiome and cognition, there is lack of translation between these studies and evidence in humans. We intend to address this gap, by assessing cognition, mood and quality of life in the context of a randomized controlled trial using probiotics. Additionally, we will examine the gut microbiome in different stages of HD, which may provide valuable understanding about disease progression.