ANZCTR search results

This is a prospective, observational registry-based study assessing outcomes of total knee and hip joint replacement surgery. The primary objective of this protocol is to determine predictors of patient outcomes collected routinely as part of the standard clinical pathway for lower limb arthroplasty performed by the participating surgeons. Predictors will include demographics, comorbidities, relevant clinical and operative details, and preoperative patient-reported pain and function measures including the Veterans-Rand 12-item quality of life questionnaire (VR-12), the Knee Osteoarthritis Outcome Score (12-item; KOOS-12), the Hip Osteoarthritis Outcome Score (12-item; HOOS-12), and the MODEMs patient expectations scale. Patient outcomes will include postoperative KOOS-12/HOOS-12 scores, self-rated kneeling ability, the postoperative component of the MODEMs expectations scale, patient satisfaction, and revisions or complications arising as a result of treatment. Recruitment will include all patients presenting with lower limb (knee or hip) pathology to the principal and associate investigators at their consulting rooms. Patients will undergo routine standard of care preoperative work-up, including the collection of demographic information, medical history, radiology, pathology, and functional analysis. Patients will in addition be requested to complete patient-reported outcome measures (PROMs) to enable evaluation of important surgical outcomes as part of the post-operative follow up. The outcomes of individual patients will be monitored up to 2 years postoperatively.

Prostate cancer is the most common in men, and the second leading cause of cancer deaths (25%) in Australia. One-in-Seven Australian men will be diagnosed with prostate cancer by aged 85, with more than 3,300 men dying each year. Our recent research has provided evidence that our new screening test using the ISET®-Circulating Tumour Cells (CTC) Test and Prostate-specific Marker Test, can improve the early detection of Prostate Cancer. Our new prostate cancer screening test is markedly more accurate (True Positives: 99%, True Negatives: 97%) compared to the existing Prostate Specific Antigen (PSA) blood test (True Positives: 25%; True Negatives: 15%). This study will determine the accuracy of a new prostate cancer screening blood test as compared to the current standard screening tests which generally involve blood tests, imaging scans and/or biopsy. Who is it for? You may be eligible for this study if you are a male aged between 50-75 years, either with no history of cancer, or if you have been previously diagnosed with prostate cancer. Study details All participants will be required to provide one blood sample at the time of enrolment into the study, which will be processed using the ISET technology to determine the number and types of Circulating Tumour Cells (CTC), as well as the levels of prostate-specific biomarkers. The CTC test report will be available for discussion with the referring doctor 2-4 weeks after the blood draw. Participants who have a positive Prostate Cancer Screening Test result will be advised to undergo further assessment via imaging and/or biopsy of their prostate tissue. The PET imaging scan will involve injection of a radioactive tracing agent into your arm with a 30 minute delay before the scan is performed. It is anticipated that the scan will take approximately 2 hours to complete. If the referring doctor determines that a prostate biopsy is required, a tissue sample will be taken under local anaesthetic by an experienced doctor. The aim of this research is to determine the accuracy of this simple blood test for the diagnosis of prostate cancer that can be used in the future as a cancer screening tool.

In this study, speech pathologists will deliver stuttering treatment to up to 30 primary school aged in Victoria, Australia. Participants will receive treatment delivered via telepractice (i.e. videoconferencing) for 9 months. The treatment is the Lidcombe Program which is a behavioural treatment approach in which parents are trained to implement treatment in the child’s natural environment. Parents are taught in weekly clinic sessions to provide verbal contingencies for stutter-free and stuttered speech in both controlled and naturalistic settings. The Lidcombe Program has previously been shown to be effective when delivered using telepractice. To date however there is no published evidence regarding the use of telepractice delivered Lidcombe Program within a primary school setting. It is anticipated that results from this trial will demonstrate that telepractice has the potential to provide effective accessible direct treatment while maximising workload and travel efficiencies for the speech pathologists,

A retrospective observational study to determine the outcomes of ICU survivors measured by the Acute Care Index of Function (ACIF) and determining factors that may effect outcome. The hypotheses for this study are: • That ACIF scores at ICU discharge will predict physical function and discharge destination at hospital discharge • That a relationship exists between patient factors and severity of illness on functional outcome measured by the ACIF at hospital discharge • That the ACIF is a valid tool to measure the functional outcome of ICU survivors

Anxiety, depression and alcohol use disorders are common, co-occurring and cause significant harm to individuals and society. It is critical to intervene early to prevent chronic and debilitating trajectories. Existing prevention programs among adolescents are limited in effectiveness and implementation. This project aims to examine the effectiveness of a personality-targeted program, Preventure, in preventing escalation of anxiety, depression and alcohol use in young Australians. It will be the first in Australia to test Preventure when delivered by school staff (rather than psychologists), enabling broader reach and reducing cost, thereby ensuring a model with the potential to be delivered to high schools nationally. The Preventure intervention consists of 2 x 90-minute group sessions that incorporate components of cognitive-behavioural therapy and motivational interviewing to promote coping skills in adolescents. A cluster randomised controlled trial (RCT) will be conducted with 6 high-schools allocated to receive the Preventure intervention, and 6 high-schools allocated to a control condition who will receive their usual Health and Physical Education curriculum (total n=900 students). Students will be followed-up for 6-months, with surveys at baseline, and 6-months.

Shoulder pain in the presence of rotator cuff tear is common and becomes more common with age. Rotator cuff tears are regularly interpreted as the cause for shoulder disability and is frequently treated with arthroscopic surgical repair. There is uncertainty about whether surgical repair provides clinically meaningful benefits to patients with symptoms attributed to their rotator cuff tear. Previous trials have shown high rates of re-tears (following repair) at one to two years; the structural integrity of the cuff after surgical repair, does not correlate with clinically important differences in pain or function; and many tears do not progress if left not repaired. Surgical management of rotator cuff tears incurs significant medical and hospital costs and associated surgical risks compared to non-operative management (for example physiotherapy). Therefore, high level evidence comparing surgery to repair the rotator cuff tear versus surgery with no rotator cuff repair (placebo surgery) is required to address practice variation, justification or avoidance of costs, and to provide the best clinical outcome for patients with these tears. The aim of this blinded, randomised, parallel group, surgery controlled superiority trial is to: determine the effectiveness, safety and cost-effectiveness of arthroscopic rotator cuff repair compared with placebo (no rotator cuff repair), in improving shoulder pain and function, and quality of life in individuals with symptoms attributed to non-acute, full-thickness rotator cuff tears. During this trial it is expected that 86 participants with completed primary outcome data will be randomly allocated to receive either arthroscopic shoulder surgery with rotator cuff tear repair OR arthroscopic shoulder surgery without the rotator cuff tear repair. The trial will also follow patients that are unwilling to be randomised (but consent to follow up) in a separate, observational arm. Inclusion of non-randomised patients provides practice and outcome insights about standard care, and improves the generalisation of the results from the randomised arms.

Since December 2019, we have been facing our third severe acute respiratory syndrome (SARS) due to a coronavirus in 18 years, known as SARS-CoV-2. There are currently few therapeutic agents and of only limited efficacy. The large majority of patients are diagnosed with a mild form of the virus. The SARS-CoV-2 virus, with its clinical syndrome known as COVID-19, is made up of spike protein (S), nucleocapsid protein (N) that contains the RNA, membrane protein (M) and the envelope protein (E). The spike protein that is responsible for initiating internalization of the virus genome into human lung cells protrudes on the outer surface and is a number of amino acids and glycoproteins. Recent insights strongly support the theory that the nose is the primary site of infection, from where the infection is prone to progress to the lung, suggesting the potential for early nasal-directed treatment. Bromelain and Acetylcysteine (BromAc®) is a palliative treatment for highly mucinous tumours of the appendix due to its ability to remove glycosidic linkages and disulphide bonds. Bromelain is already known to remove the spike protein and haemagglutinin of similar viruses, including Semliki Forest virus, Sindbis virus, mouse gastrointestinal coronavirus, hemagglutinating encephalomyelitis virus and H1i1 influenza viruses, rendering these non-infective, Acetylcysteine has already been used as an anti-viral. It inhibits influenza A and induced production of pro-inflammatory molecules in lung epithelial cells. In a murine model of lethal influenza infection, an increased survival was seen in the acetylcysteine combination with oseltamivir group (100% vs 60%). We predicted and have now shown that BromAc® can disrupt and completely cleave the glycoproteins of the SARS-CoV-2 virus, which have a detrimental effect on the virus, rendering it non-infective. We believe that BromAc® may be suitable in clinical application with delivery intranasally in swab PCR positive SARS-CoV-2 outpatients. This drug has the potential to reduce infectivity of those with SARS-CoV-2, potentially reducing exposure to close contacts and progression of the disease into COVID19 syndrome, and act as a prophylactic to prevent the virus from binding to host cells.

The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious seen in recent pandemic history. One of the major impacts of COVID-19 is the long-standing financial stress that it is imposing on millions of people worldwide. Unemployment, under-employment, and other forms of financial stress are causing marked increases in depression, anxiety, and suicide risk. There is an urgent demand for programs that can address the effects of financial stress experienced by people during the COVID-19 pandemic. There are major challenges in dealing with this issue because this mental health problem is affecting unprecedented numbers of people, it is affecting people all across Australia and beyond regions traditionally serviced by mental health services, and people are limited in accessing health services in the context of social distancing. A suitable and evidence-based program that helps to cope with stress in times of crisis is the Problem Management Plus (PM+), which was developed by the World Health Organization. As a low-intensity intervention for adults affected by adversity, this program teaches people well-documented strategies to manage stress. This project aims to conduct a rapid trial of a brief psychological intervention, termed Problem Management Plus (PM+) to reduce distress associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This project does not aim to treat a mental disorder but rather alleviate distress and improve coping in people with distress about COVID-19. This brief program will be offered via teleconferencing to allow for social distancing on a group basis. We hypothesise that PM+ will result in greater reductions in distress and worry relative to provision of currently available online resources to manage distress. Adults who screen positive for psychological distress will be randomized to PM+ or a control condition. PM+ will comprise 7 x 60-minute sessions delivered by a clinical psychologist via teleconferencing to groups of 4 people at a time. The control arm will direct people to a portal with stress coping strategies. All participants will be assessed at baseline, post-intervention, and 3 and 24 months follow-up.

Hypertrophic cardiomyopathy (HCM) is an inherited condition that results in an abnormally thickened heart muscle. It is the most common inherited heart muscle condition affecting up to 1 in 200 of the general population. The genetic mutation (or “spelling mistake” in the genes) leads to inefficient heart muscle contraction, and over time it leads to heart muscle thickening. The thickness of the heart muscle is one of the most important predictors of symptoms in patients with HCM. Treatment of HCM has focussed on relief of symptoms by medications which slow the heart rate and improve heart function. However, the symptom relief is incomplete and there is no evidence of medications to reverse abnormal heart muscle thickening. Perhexiline, a drug currently used safely as an anti-anginal agent, increases the energy efficiency of the heart. The principal driver of increased muscle thickness in HCM is energy depletion of cardiac muscle cells. As Perhexiline improves energy efficiency in the heart, there are plausible reasons (not yet tested) that it may reduce heart muscle thickness as well as improve patient symptoms. We aim to study the effects Perhexiline treatment on heart muscle thickness in symptomatic HCM patients. If our study is positive, it would lead to the design of a definitive clinical trial that would address the question whether Perhexiline use reduces heart failure and sudden death events in HCM patients.

Peripheral Vascular Disease (PVD) is a common condition often treated with angioplasty, a minimally invasive endovascular procedure to widen narrow or obstructed arteries or veins, typically used to treat atherosclerosis. Removal of the femoral sheath requires adequate compression which can be achieved by manual compression (MC) or with the use of vascular closure devices (VCD). The aim of this study is to evaluate the safety of the FemoStop™ II Gold compression system post-peripheral angioplasty in patients with PVD. The study will also aim to analyse rates of groin complication between the FemoStop™ II Gold compression system and VCD, allowing physicians to better decide which method has least post-operative complications and better patient satisfaction.