ANZCTR search results

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.

This study is a 16-week, progressive exercise intervention, designed to improve bone mineral density in post-menopausal women with low bone health. Participants will have bone density assessments at the beginning and conclusion of the trial, along with strength measurements and blood biochemistry tests throughout the study. All participants recruited to the study will take part in the exercise intervention. Participants will also be fitted with a prototype wearable device which we have developed, capable of measuring the forces experienced by their skeleton during these exercise sessions. The aim of this study is to improve bone mineral density, along with other musculoskeletal factors in older adults.

We aim to examine the effect of a stress on the secretion of endocannabinoids (anandamide & 2AG) and stress hormones (cortisol) in saliva. We hypothesise that participants who undergo a stressful task will display a distinct pattern of endocannabinoid and cortisol reactivity. Firstly, we expect that endocannabinoid anandamide will rapidly decrease (within 10 minutes). Secondly, we predict that this decrease will be correlated with subsequent cortisol increase (peaking about 30 minutes following stress), and that this cortisol increase will be associated with increased 2-arachidonoylglycerol (2-AG) at approximately 45 minutes following stress. In males, we will examine the validity of endocannbinoid levels in saliva samples via a comparison with levels in blood serum. A second aim is to examine the effect of stress on cognitive functioning in females, including measures of brain activity from the scalp. We hypothesise that executive control will be impaired following acute stress, whereas performance on automatic attention tasks will improve.

A significant barrier to donation and donor retention is fear of needle pain, pain actually experienced during phlebotomy, and associated anxiety. It is clear from previous research that anticipatory anxiety and/or fear of needle pain does not dissuade all prospective donors, however these inter-related barriers have negative consequences for donor retention. Donors reporting higher levels of anxiety and fear of needle pain are more likely to experience a vasovagal reaction, including full faint and/or presyncopal symptoms such as faintness, dizziness, and light-headedness. A recent study by France et al (2012) found that fear of injections and blood draws had the strongest relationship to post-donation Blood Donor Reaction Inventory (BDRI) scores, a self-rated measure of presyncopal reactions to blood donation. A particularly strong relationship between fear related to blood donation and adverse events was noted for female, first time donors. The findings of this study are consistent with other research showing that pre- donation fear, as measured by a single question about fear of needles, was positively related to post- donation BDRI scores and inversely related to ratings of likelihood of future donation, as well as actual rates of return in the subsequent year 7. Interestingly, this effect appears to be dependent on actual reaction occurrence, suggesting opportunities to intervene to reduce fear, anxiety, and adverse reactions are critical to improving retention. In addition, it is well-documented that donor adverse events with or without self-report of fear/anxiety are related to future intention to donate and are an independent predictor of retention, particularly for first time donors. For example, France, Radar, & Carlson (2005) reported, in a 1-year prospective study of nearly 90,000 blood donors, return rates of 64% for individuals without an adverse reaction, in comparison with just 40% for those who did experience a reaction. Although there are few studies examining pain and donor behaviour, there is evidence that blood donors who report lower levels of needle pain are typically less anxious, and lower needle pain ratings have been associated with greater donation satisfaction, which is in turn related to intention to return to donate. Taken together the research to date suggests that provision of methods that reduce or even eliminate pain and/or reduce anxiety and fear are likely to enhance the safety and comfort of blood donors and improve retention. Recently a small study (publication pending) was conducted to assess the feasibility of using the Coolsense(R) device in a blood donation setting and results showed that it was generally well tolerated and accepted by donors and staff. Therefore the aim of the this next trial is to assess the efficacy of the Coolsense(R) device in reducing the pain experienced by whole blood donors during phlebotomy

The primary aim of this research project is to investigate whether the way we report clinical imaging findings impacts patient perception of treatment efficacy in midsubstance Achilles tendinopathy. This study is a parallel group, randomised controlled trial with an 8-week follow-up. Participants will be randomised into receiving a standard imaging report based on conventional imaging practice or an evidence-based imaging report with the aim of stating that their imaging does not reflect their clinical symptoms. Both groups will receive a one-on-one explanation of their imaging explaining that imaging does not reflect their clinical symptoms. Primary and secondary measures will be collected at baseline, 4 and 8 weeks. The primary outcome measures are 7-point patient global impression of change and the Tampa scale of kinesiophobia. Secondary outcome measures are the VISA-A score and severity of pain during the previous week.