ANZCTR search results

1. Background Urethral strictures often cause problems in men. The best way to fix urethral strictures is with mucosa from inside the cheek. This mucosa is then grafted inside the penis. We want to find out what problems may occur inside the mouth after this operation. We also want to find out if problems are more common in some men. To do this, we will collect some of your information, like age and your medical problems. We will also record any problems or pain you had after your operation. By doing this, we will better understand mouth problems that arise after taking the mucosal graft. Then in the future, doctors will be better able to inform men about how common these problems are. 2. Aims The primary aim is to explore oral Quality of Life in men who will undergo buccal mucosal graft harvesting for urethroplasty at Toowoomba Hospital and St Vincent’s Private Hospital from 1st March 2020 onwards. Secondarily, this study will evaluate the occurrence of post-operative complications at the buccal mucosal graft donor site. This study will also investigate if certain demographic, medical, and operative variables are associated with post-operative complications and poorer oral quality of life. 3. Hypothesis Post-operative complications at the buccal mucosa graft donor site result in a poorer oral quality of life.

In a randomised controlled trial (including 3- and 6-month follow-up), the current study will investigate the efficacy of a stepped care approach for treating PTSD in adults. The key research question is whether an online stepped care approach can clinically improve PTSD at a comparable rate to traditional high-intensity PTSD treatment, Cognitive Processing Therapy (CPT) delivered via video call. . The study will also examine potential predictors of clients’ response to low- versus higher-intensity therapy (e.g., PTSD severity, co-morbidity with other psychological disorders, and therapeutic alliance). The feasibility of online stepped care will be evaluated by comparing cost-effectiveness, ease of delivery, and acceptability of the treatments as rated by clients. Overall, it is hypothesised that stepped care would be comparable over time to CPT in terms of posttraumatic stress severity (primary outcome), depression severity, quality of life, and acceptability as rated by clients. Stepped care is predicted to have equivalent PTSD severity reductions to CPT as assessed by a standardised diagnostic interview instrument (CAPS-5) to CPT at 6-months post-treatment. However, Stepped care is predicted to cost significantly less that CPT in terms of the amount of therapist time required and economic evaluation of quality of adjusted life years.

Protocol: Kidney transplant recipients will be screened and enrolled at week 3 following transplantation. Participants will be randomised (1:1) to receive at 4 weeks post-transplant either inulin (intervention) or continue with standard care. Subjects randomised to receive inulin will be asked to drink 10g of inulin dissolved in 200ml water once daily for one week, and then twice daily for a further 3 weeks. Subjects randomised to standard care will be instructed to consume the same quantity of water, without additional supplementation. Compliance with fibre supplementation will be assessed by powder weight every 7 days. All participants will receive standard post-transplant care including immunosuppression and medication use will be recorded throughout the study. Participants will be asked to keep a 4-day food diary prior to and during the final 4 days of supplementation, to be analysed using Foodwerx. Subjects will undergo continuous glucose monitoring for 2 periods of 14 days, from week 3 and week 7 post-transplant, to measure insulin resistance (HOMA) and glycaemic control (mean glucose, time in diabetic range, GRADE and MAGE scores). Kidney function (eGFR, albuminuria) and allograft response (kidney biopsy and test for donor-specific antibodies) will be assessed at month 3 and at any time of graft dysfunction. Patients will provide blood and faecal samples for analysis of SCFA (serum and stool, by NMR spectroscopy) and microbiota/metagenome (stool, by 16s rRNA sequencing) at (1) pre-supplement; (2) last week of supplementation; (3) at month 3 post-transplant. Gut homeostasis (blood Zonulin, LPS, CRP, IL-6, IL-17) and symptoms (Gastrointestinal Ratings Scale), cardiovascular risk profile (lipids, blood pressure, weight, CVD events), infections and hospitalisations will be recorded.

The purpose of this study is to determine if APOMAB, (an imaging agent which is an antibody with a small amount of radiation attached to it) which has been designed to detect tumour cell death, is safe and tolerable to use in humans. The APOMAB trial will be done in two stages. In the first stage of the trial in 6 participants, you will receive the APOMAB injection if you have an advanced lung or ovarian cancer but only if you are not receiving any chemotherapy at the time that the APOMAB injection is planned. In the second stage of the trial in 12 participants, you will receive the APOMAB injection after the first cycle of standard chemotherapy for your advanced lung or ovarian cancer. If you are an adult, have received a new diagnosis of advanced lung or ovarian cancer, and you have either commenced or are about to commence platinum based chemotherapy, then you may be asked to consider participating in this study, and if you agree, then you will be asked to sign a consent form. There are a number of tests and procedures which need to be carried out to determine if you would be eligible to take part in this study. This is called the 'screening period', and can take up to 14 days to complete. During this period you will be reviewed by a doctor who will take a full medical history, perform a physical exam, an ECG ( a non-invasive test of the electrical activity of your heart), routine blood tests, collection of small amount of blood for study purposes, a FDG-PET/CT scan if this has not been recently performed, once all test results have been reviewed and the study doctor confirms that you are eligible for the study, a date will be organised for you to receive an injection of the study drug APOMAB. Prior to the injection, the study doctor will review you again, you will remain at the imaging centre for approximately 4-5 hours post injection, as a number of scans will be collected as well as blood and urine samples on this day. You will be required to undergo further medical reviews and scans, with further blood and urine samples to be collected on Days 2, 4, 8 & 13 post injection. No other visits will be required for study purposes. You will then either commence or continue your standard chemotherapy treatment. The results of this study will help further the development of immunoPET/CT with APOMAB. We are aiming to find out whether an early indication of tumour cell death on APOMAB immunoPET/CT scans before a patient has a second cycle of chemotherapy increases the likelihood that tumours in the body shrink. Having this information sooner in the treatment course may allow future cancer patients to know that effective treatment can continue even in spite of side effects. Also future cancer patients can know that ineffective treatment can be discontinued, thus avoiding side effects without any prospect of benefit, and allow these patients to choose an alternative treatment sooner rather than later.

The incidence of Acute Kidney Injury (AKI) is increasing, with Australian and US Medicare data illustrating striking increases over the decade following 2000. Up to 20% of adult patients experience AKI during their hospitalization, with mortality rates as high as 45%, and AKI is a global healthcare issue that has significant impacts on patients’ quality of life. In the absence of proven therapies to prevent or even treat AKI, it is likely that the current growth in incidence will continue into coming years. Almost all the randomised trial evidence in AKI arises from patients with severe AKI requiring renal replacement therapy (RRT) in the ICU setting. The non-ICU burden of AKI is much larger, such that interventions in this area are likely to have a much greater impact upon AKI globally. In addition, as novel treatments are developed to address the poor outcomes of AKI, these non-ICU patients will be central to the testing of these treatments. Current literature regarding non-ICU AKI are mainly derived from retrospective studies and administrative data. Two large administrative studies have demonstrated an approximate rise in incidence of AKI by 20 episodes per 1000 discharges between 1990 and 2000, with local Australian and New Zealand data also showing similar increases in ICU patients. However, the incidence of AKI in the non-ICU setting using a prospective study is poorly-known due to underreporting, differences in the AKI definition and case mix. The PERFORM-AKI study will provide initial unique insights into the burden of non-ICU AKI and form the basis of understanding the potentially remediable factors that might be amendable to modification in order to improve long-term outcomes of survivors following AKI.

In December 2019, several cases of atypical pneumonia caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were reported in Wuhan, China. This novel virus has now become responsible for a pandemic (COVID-19). In most of cases, COVID-19 is a self-limited lower respiratory tract illness. However, in some patients, it causes acute respiratory distress syndrome (ARDS), shock, myocardial injury, acute kidney injury, and multiorgan failure develop. A significant proportion of mechanically ventilated patients with COVID-19 infection require vasopressor support. Conventional and recommended agents used for such support include norepinephrine and vasopressin. Angiotensin II may be a suitable agent in patients with COVID-19 because of its potential nephroprotective effect, its potentially ability to specifically assist in patients recently exposed to angiotensin converting enzyme inhibitors (ACEIs), and because of its potential to affect the internalization and downregulation of angiotensin converting enzyme 2 (ACE2). This is relevant to COVID-19-associated critical illness because ACE is both the protein responsible for the break-down of angiotensin II to Angiotensin 1-7 and is the receptor for the viral entry into the cells. The primary aim is to generate an international, multicentre network of integrated care for patients with COVID-19 treated with angiotensin II or other novel therapy to monitor safety and to monitor outcomes. The hypothesis is that, in patients with COVID-19 receiving angiotensin II or novel therapy, additional evidence of benefit or harm can be identified, improved and used to guide further research in the field with the implementation of an international angiotensin II registry.

The purpose of this trials is to assess the effect on visual performance when spectacles lenses are prescribed in 0.05 D steps compared to when they are prescribed in 0.25 D steps

The purpose of this trial is to see if a reduced radiotherapy can deliver equivalent treatment response to full dose radiotherapy for patients with skin cancer. Who is it for? You may be eligible for this study if you are aged 50 or older and have non-melanoma skin cancer. Study details Participants in this group will receive one of two treatments. This is determined by patient preference and medical officer recommendation. Both groups will have the reduced radiotherapy dose for 5 weeks, either as five doses per week with a week between treatment weeks; or as 3 doses per week for 5 weeks. Both groups will receive the same dose. The purpose of this trial is to see if a reduced radiotherapy can deliver equivalent treatment response to full dose radiotherapy for patients with skin cancer. A total of 100 participants will be recruited with the study across selected GenesisCare Sites within Australia. It is anticipated that it will take 36 months to complete the accrual of 100 participants. All participants will be followed for another 12 months after the end of accrual, giving the trial a total duration of 48 months (4 years).

The safety of staff during high risk aerosol generating procedures such as airway intervention is paramount. Currently, there is no high-quality evidence or standards available, with the current process for airway intervention based on experiences with SARS & COVID19 in other countries. We are currently auditing our internal process however acknowledging our numbers are low, we have reached out to other hospitals in NSW. The goal is to combine survey data with other hospital sites in NSW to analyse a larger dataset to draw more meaningful conclusions. The goal is to address any weaknesses in our safety process of PPE & intubation technique to ensure staff safety.

Viral bronchiolitis is the most common cause of hospital admission in infants. Annually at the Queensland Children's Hospital approximately 500 infants are admitted overnight. It is common for infants with moderate to severe respiratory distress to be commenced on continuous nasogastric feeds. This is based on an anecdotal hypothesis that it will reduce the risk of pulmonary aspiration and decrease splinting of the diaphragm which reduces respiratory effort. No published evidence could be found to support this. The process of upgrading from continuous to bolus to oral feeds can take 24-72 hours, likely prolonging admission and contributing to the burden of bronchiolitis on families and the health system. The aim of this study is to establish whether continuous nasogastric feeding prolongs hospital length of stay in infants admitted with a clinical diagnosis of bronchiolitis. The inter-departmental study also aims to establish that bolus nasogastric feeding in bronchiolitis is not associated with the adverse outcome of aspiration or paediatric intensive care admission.