ANZCTR search results

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.

The Queensland Children’s Hospital and Perth Children’s Hospital have identified a need to determine if SASS is superior to SSD for PICC and tunnelled CVC securement for; a) patients requiring PICC that have compromised skin integrity and b) all patients requiring insertion of tunnelled CVC. The results of this study will inform paediatric healthcare practice, provide reliable estimates of the comparative effect of SASS, and inform the feasibility of conducting a larger, definitive trial. We have completed an inbuilt feasibility study (n=60) and are continuing on to a powered RCT.

This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of: • Screening period: up to 14 days (defined as Day -23 to -9) • Washout period: 5 days (± 1 day) (defined as Day -8 to -4) • Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing) • Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing) • Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose) Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms: • Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002 • Arm B: 10 patients will receive 10 µg BIW OLP-1002 • Arm C: 10 patients will receive Placebo BIW

This study will examine the impact of the National Bowel Cancer Screening Program (NBCSP) on colorectal cancer outcomes for people over the age of 50 with severe mental illness. Who is it for? This retrospective study will be looking at data on people aged 50-74 and who have participated in the NBCSP, with or without severe mental illness. We will also be consulting with people with severe mental illness and their carers on barriers to screening and optimal care. Study details This is a data linkage study of multiple Commonwealth datasets: NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database and the National Death Index. Data linkage with NSW Cancer registry and hospital data will also be used. This research project is directly focused on identifying where access and/or treatment disparities exist along the colorectal cancer care pathway for people with severe mental illness in order to improve access and service utilisation, and ultimately to improve cancer survival for this very disadvantaged group.