ANZCTR search results

A hernia is a bulge of bowel or other abdominal organs through a weakness in the abdominal wall muscles. A ventral hernia is a type of hernia through the abdominal wall which appears in the middle of your abdomen. It may appear as a lump or bulge, and over time may increase in size and cause pain. This type of hernia can be caused by previous abdominal surgery, weak abdominal muscles, heavy lifting, pregnancy and other causes of weakness of the abdominal wall. When required, a hernia may be repaired surgically using either keyhole surgery (laparoscopic surgery) or a larger incision (open surgery). The goal of surgery is to repair the weakness in the abdominal wall to prevent the abdominal contents protruding through and causing a bulge and pain, and preventing strangulation of those abdominal contents. As part of the procedure, it is standard practice to place a supporting sheet of mesh to act as a reinforcing patch and to help strengthen the abdominal wall and keep the abdominal contents in place. Surgeons can use either sewing stitches (sutures) or tacks (small metallic fixtures) to secure this patch in place. Both of these methods are routinely used in this type of operation. The purpose of this study is to to see if suture repain is less painful than the tack repair and improve mobility for patients following this procedure. We will do this by comparing the two different surgical techniques used to secure the mesh in place.

Approximately 4.1 million Australian adults suffer from hypertension, which was estimated to cause 26,000 deaths in Australia in 2017. Excess dietary salt consumption is a leading cause of high blood pressure, and dietary guidelines specifically recommend the avoidance of foods high in salt for blood pressure lowering. Yet, current individual-based education and clinical counselling to reduce salt intakes has shown limited effectiveness, is resource intensive, costly, and has limited reach. Hypertensive patients in Australia currently consume on average ~10g salt per day, nearly twice the World Health Organisation recommended maximum; with most (~80%) dietary salt derived from eating packaged and processed foods. Thus, innovative strategies are urgently needed to help hypertensive patients reduce their dietary salt intake. The overall goal of this research is to determine the effectiveness of a novel, scalable, and sustainable salt reduction intervention (online grocery shopping, OGS) for lowering blood pressure (BP) amongst patients with hypertension. We will do this by conducting a large-scale randomised controlled trial (RCT) using an online grocery shopping intervention designed specifically for Woolworths, Australia’s largest online grocery retailer. The OGS will be provided to the study participants as a web-browser application, such that every time participants purchase groceries online, OGS will provide immediate on-screen, interpretive (i.e. colour-coded symbol) nutrition information and specific suggestions for lower salt alternatives. The personalised approach – consumers can maintain their usual dietary patterns and are guided to choose similar, but lower-salt alternative products – offers flexibility and caters to personal preferences. If this intervention demonstrates even a 2 mmHg BP lowering effect, then it would be meaningful because 2 mmHg lower BP translates into an approximately 10% reduction in premature cardiovascular disease (CVD) amongst hypertensive patients. There is currently no other platform that could improve dietary behaviours more rapidly to reduce BP amongst Australians. The OGS online grocery shopping intervention has the potential to have a major effect on BP control and prevention of CVD in Australia and globally.

68Ga NODAGA GSAO is a new radioactive compound that when injected allows a different type of PET scan to be performed to directly image dead and dying cells. This study aims to determine how 68Ga GSAO is taken up by both cancer and non-cancer cells in a small group of cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a histologically or cytologically confirmed solid cancer with at least one measurable lesion >2 cm and you meet pre-specified requirements for liver and renal function. Please note that patients with primary or metastatic brain or spinal cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will be injected with 68Ga NODAGA GSAO and following this they will undergo a total of eight PET imaging scans (during which they will be required to lie still on a scanning bed breathing normally). The first six scans will be performed one after the other (total duration of approximately 90 minutes). Participants will then have a break and then undergo two further scans each taking approximately 30 to 40 minutes (with a break in between). Participants will also have blood and urine samples collected to determine the amount of 68Ga NODAGA GSAO in blood and excreted in urine. The total duration of the study will be approximately five hours. Patients will also be followed up for 7 days after 68Ga NODAGA GSAO PET scanning to determine if they have experienced any side effects from the injection. It is hoped this research may be used to improve health outcomes for future cancer patients by investigating the safety and usefulness of the 68Ga NODAGA GSAO PET scan to image cancer cell death as a way of determining cancer treatment response earlier and more accurately than currently available imaging methods.

Aboriginal and Torres Strait Islander people residing in remote communities experience the highest reported rates of food insecurity in Australia. We will test an intervention to improve diet quality for women and children, by making healthy food and drinks more affordable. Price discounts on a range of healthy food and drinks will be accessible to participants via loyalty cards, with discounts being advertised in store and locations frequented by the participant group. This research will enhance our understanding of the impact of price discounts on diet quality. We hypothesise that participants in intervention vs. control communities will have a greater increase in dietary quality from baseline.

The PARAGON-II clinical trial seeks to improve outcomes for post-menopausal women with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. The study aims to investigate if the combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates, as compared to historical controls from the PARAGON trial, in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated. Who is it for? You may be eligible for this study if you are aged 18 or older, with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. Study details Participants will be allocated to one of the two treatment groups based on the PIK3CA mutation status, then followed-up to see if outcomes are improved and what side-effects occur. Clinical assessment, imaging, blood tests will be performed. CA125 tumour and Patient Reported Outcomes will be also be assessed during the study. It is hoped that combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated.

With every respiratory exacerbation of CF, approximately 25% of patients do not return to their baseline lung function. Preservation of lung function is important for extending life and for quality of life, thus there is a need to determine the most effective empirical treatments of exacerbations. Antibiotics are a cornerstone of treatment. Most antibiotic regimens are only informed by old, underpowered, or poor-quality trials. Across Australia, CF centres use a range of approaches and antibiotic regimens. No consensus exists on the treatment of pulmonary exacerbations of CF. In addition to numerous antibiotic options, there are other unanswered questions pertaining to the use of mucolytic agents, anti-inflammatory medication and chest physiotherapy, alone and in combination. The range of regimens used for treating CF exacerbations cannot be feasibly compared using conventional clinical trials (comparing one treatment at a time to another treatment or placebo) due to the large number of comparisons that are needed. The aim of BEAT CF is to optimise the management of lung exacerbations in people with CF by systematically evaluating the effectiveness of alternative treatment options, and by implementing these findings in routine care on an ongoing basis. The initial, platform phase of BEAT CF involves the platform database. The platform collects treatment and outcome data in an efficient way from the medical records of participants, for the purpose of evaluating the comparative effectiveness of alternative treatments. The BEAT CF platform is intended to support the data capture for future, nested clinical trials. Details of any future clinical trials will be available separately as and when they are written.

SARS CoV-2 (COVID-19) is highly infectious, with each case transmitting infection to between 2 to 3 other people. Approximately 15% of COVID-19 infected individuals are hospitalised and 1 in 3 require artificial ventilatory support. Up to a third have a poor prognosis with the main cause of death being overwhelming respiratory failure and/or cardiac failure and cardiac arrest associated with a cytokine storm. Approximately 30% of hospitalised individuals will ultimately require artificial ventilatory support for deteriorating respiratory status while under clinical observation. Conservatively, at least one third of intubated people will succumb to the infection with the most common causes of death being overwhelming respiratory failure associated with acute respiratory distress syndrome (ARDS) and/or cardiac failure and cardiac arrest, both associated with cytokine storm. Over 1.9 million individuals of the 46 million infected individuals globally have died from COVID-19 infection (as of January 2021), with many more deaths projected over the next 6-12 months. Fatal outcomes are thought to be driven by inflammatory responses to the virus resulting in host-mediated tissue damage to the lung, heart, and kidney and a prothrombotic milieu. Approximately 10% of patients with COVID-19 suffer from symptoms beyond 3-4 weeks, labelled as ‘long COVID-19.’ A variety of symptoms are experienced including cough, breathlessness, fever, sore throat, chest pain and cognitive deficits. Oral colchicine has demonstrated striking anti-inflammatory properties in patients with vascular disease and a “single shot” of colchicine markedly suppresses monocyte inflammasome activation, which is pivotal in the cascade leading to the cytokine storm. Troublesome side effects with colchicine appears to be rare. Thus, this treatment may reduce the serious complications associated with COVID-19 and non-COVID-19 ARDS.

Medications to treat rheumatoid arthritis and psoriatic arthritis have possible side effects. People may be unwilling to take them if they are unaware of the benefits. Educational tools using pictures may improve people’s understanding of arthritis and medications. Musculoskeletal ultrasound (US) is useful in assessment of joint inflammation and damage. It is portable, non-invasive, and allows joint structures to be seen in "real-time". It may be rapidly done by a trained user. There is strong evidence that US is of value in monitoring the severity of rheumatoid arthritis and psoriatic arthritis. Recent work by our research group has shown that patients found real-time US more useful than written leaflets or online information for understanding rheumatoid arthritis and medications used to treat it. The aim of this study is to determine if showing people with rheumatoid or psoriatic arthritis “real-time” US of their inflamed joints: i) improves their willingness to take an extra medication which turns off inflammation (Disease Modifying Anti-Rheumatic Drug, or DMARD) and ii) increases their willingness to keep taking this medication (medication adherence) This research has been initiated by the study doctor, A/Prof Peter Wong. This research has been funded by investigator-initiated grants from Pfizer. The funding bodies have no input into conduct of the research.

Takotsubo syndrome, also known as the broken heart syndrome, is an acute and commonly reversible heart dysfunction characterised by changes in the structure of the heart. The condition is frequently triggered by a sudden physical or emotionally stressful event. It has long been postulated that an excess of the “fight or flight” hormones adrenaline and noradrenaline (collectively called catecholamines) caused by substantial activation of the sympathetic nervous system in the heart might play a key role in the development of this syndrome. However, this has not yet been proven, and the exact mechanism of Takotsubo syndrome remains subject to debate. The research project aims to better understand the biological mechanisms that cause this syndrome. In this study, we will, for the first time, directly measure the amount of catecholamines released from the heart in affected patients and explore its association with impaired heart function characteristic of the condition. Understanding the relevant mechanisms will allow more tailored therapies to further improve the management and outcomes of patients suffering from broken heart syndrome.

This trial aims to determine the effect of cognitive bias modification on fear of cancer recurrence or progression in patients with breast and ovarian cancer. Who is it for? You may be eligible for this study if you are aged 18 or above, have been diagnosed with a breast or ovarian cancer (unless you are receiving palliative care), and are currently struggling with a fear of cancer recurrence or progression. Study details Participants will be randomly allocated (by chance) to receive cognitive bias modification training (CBM) or a placebo. . CBM is an intervention that is administered online and trains people not to interpret ambiguous situations in a threatening way. Participants will receive four cognitive bias modification sessions over the duration of 14 days and will be required to answer a number of questionnaires before the trial, and both 14 and 28 days after the trial has commenced. It is hoped that this study may demonstrate that cognitive bias modification is effective in reducing fear of cancer recurrence and progression in patients with breast and ovarian cancer, and may help to reduce pain, anxiety, and depression, and improve quality of life.