ANZCTR search results

This is a study to evaluate the safety, tolerability, and effectiveness of intranasal REVTx-99 in adult volunteers with a history of allergic rhinitis to rye grass pollen. The study has 2 parts (Part A and Part B), in which each participant will be enrolled in only 1 part, and within each part there are 2 treatment periods (Period 1 and Period 2) that each participant will complete in a crossover manner. Part A will assess the effectiveness of REVTx-99 as a preventative for allergy symptoms and Part B will assess the effectiveness of REVTx-99 for treatment of allergy symptoms. Participants will receive both REVTx-99 and Placebo in both parts.

Cancer patients/survivors have complex care needs beyond daily living assistance. They need a range of medical and allied health services as well as support for their daily living. The purpose of the study is to implement a pilot intervention of a practice nurse-led home care package administration aiming to improve your functional status, health-related quality of life, experiences of care and health service utilization. Who is it for? You may be eligible for this study if you have have cancer have previously had cancer and are receiving home care services. Study details All participants have equal chances to be allocated to Group One or Two. Group One will receive additional support and ongoing monitoring from a practice nurse. Group Two will continue to receive home care services as usual. Both groups will continue with usual medical and nursing care. It is hoped that this study will help determine whether additional support is beneficial to those who have cancer or have survived cancer.

Low back is the leading cause of disability globally. Despite this, effective treatments are limited and narcotic use is alarmingly high. Metformin is a widely prescribed, safe and low-cost medication been used clinically for over 50 years as first-line therapy for type 2 diabetes. Recent evidence has shown that metformin can inhibit the mTOR pathway which is a major contributor to pain hypersensitivity, while human clinical studies show preliminary evidence that metformin may reduce pain in individuals with chronic low back pain. A randomised clinical trial is urgently needed to determine if metformin is effective in the management of individuals with chronic low back pain. AIMS: To examine the efficacy of metformin compared to placebo on pain intensity over 4 months in individuals with chronic LBP. HYPOTHESIS: We hypothesize that metformin will be more effective in reducing pain in individuals with chronic low back pain compared with a placebo. PARTICIPANTS: 124 participants with chronic low back pain. INTERVENTION: Metformin (2000 mg) once daily COMPARATOR: Identical placebo once daily OUTCOME: Change in back pain intensity at 4 months SIGNIFICANCE: Given the large and growing burden of low back pain and it associated costs, this trial has the potential to deliver enormous health, economic, and social benefits. The repositioning of metformin, a cheap, safe, old drug for this new indication, offers an unprecedented opportunity to significantly and immediately impact the management of low back pain globally.

This proposal will address these gaps in two ways, by: (1) developing and evaluating an iSupport Virtual Assistant (VA) to support dementia carers through a partnership of four APR countries: Australia, Indonesia, New Zealand, and Vietnam; and (2) building capacity of researchers and Non-Government Organisation (NGO) partners to support this development and evaluation. Seven versions of iSupport VA will be evaluated in Australia, Indonesia, New Zealand and Vietnam using a pilot RCT. Feasibility, acceptability, intention to use, and preliminary impact on carer perceived stress of the iSupport VA intervention will be assessed.

Pain relief is considered a fundamental right in medicine. With over 80% of patients reporting pain after surgical procedures, adequate postoperative analgesia is essential to patient care. However, pain management is complex and requires the consideration of many factors including the specific surgical procedure, patients’ needs, and their perceived analgesic control. Opioid prescriptions for non-cancer-related indications, including postoperative reasons, have been increasing in recent years. While often effective for acute pain, opioids are addictive and have numerous side effects, the most serious being respiratory depression. In the United States, there are 530 opioid-related deaths every week and the opioid epidemic has been recognized as a public health emergency. The many nonfatal health consequences of opioid abuse and addiction in Australia contribute to an annual cost of $15.7 billion. In Australia, opioid-related deaths in adults between 15-64 years of age have increased by 3.8% per year since 2007. In New Zealand, the figures are similar, with the rate of opioid-related deaths increasing by one-third in total from 2001 to 2012. Globally, the overprescription of opioids after common surgical procedures is a well-recognized contributor to the opioid epidemic, including in Australia. Opioid initiation post-surgical hospital visit leads to chronic use in a small but significant proportion of patients. Similarly, there are a wide variety of reasons for overprescribing. Awareness of opioid prescription practices locoregionally can advise targeted interventions to change prescribing patterns and reduce the overprescribing of postoperative discharge opioids. The aim of this prospective multi-centre cohort study is to describe the correlation between discharge opioid prescriptions to consumption by patients after common surgical procedures and the impact on patient-reported outcomes.

We aim to assess the impact of pregnancy on the pharmacokinetics of sugammadex for reversal from rocuronium-induced neuromuscular blockade in patients undergoing caesarean delivery under general anaesthesia. Hypothesis: We hypothesise that the pharmacokinetic parameters of sugammadex (absorption, distribution, and metabolism) are different in pregnant women compared with those in non-pregnant patients. Methods: This is an observational open-labelled plasma pharmacokinetic study examining the perioperative pharmacokinetics of a single bolus intravenous (IV) dose of sugammadex in women undergoing elective caesarean delivery under general anaesthesia at the Royal Brisbane and Women’s Hospital (RBWH).

The aim is to evaluate the efficacy of an online intervention program which is focused on reducing participants' sense of perfectionism and reducing subsequent behaviours and symptoms related to having high levels of perfectionism. The intervention will target individuals who are considered at risk of developing an eating disorder due to their current disordered eating behaviours, as perfectionism is thought to contribute to the development and maintenance of eating disorders. The trial will investigate whether using an online interactive program is more effective at reducing disordered eating symptoms compared to dydactic PDF handouts or a waitlist (control) condition. The trial will investigate the perfectionism intervention's efficacy by assessing participants' self-report measures of disordered eating behaviours and perfectionism. The content for the intervention is adapted from the self-help book “Overcoming Perfectionism” (Shafran, Egan, & Wade, 2010), which has been evaluated on numerous occasions, including online formats, and found to improve body image flexibility and decrease disordered eating. Session content covers: psychoeducation, self-criticism and self-compassion, unhelpful thinking styles, procrastination, self-worth, maintenance cycles, and perfectionism misconceptions. The content for the dydactic handouts can be accessed from https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Perfectionism

This study aims to evaluate the effectiveness of a combined 6 week Cognitive Rehabilitation and Psychological intervention delivered via Telehealth in improving patient outcomes post-stroke in a pragmatic randomised wait-list controlled trial. It is expected that the proposed intervention will improve patients’ cognition, psychological wellbeing, functional abilities and QoL. Eighty participants with a diagnosis of stroke within the previous 6-months and self-reported cognitive or psychological difficulties referred to the ISLHD Rehabilitation and Medical Psychology Department by multidisciplinary teams on Rehabilitation and Neurology wards within ISLHD, will be randomised to a 6-week combined Cognitive Rehabilitation and Psychological Telehealth Intervention or Waitlist Control Group. Participants will attend an assessment session prior to the Group, immediately following the Group, and at 3 months follow up after completing group, and will be assessed with a varied of neuropsychological tests (primary outcome measure being RAVLT) and psychological wellbeing measures (DASS-21) and quality of life(SF-36) .

The SOCRATES HCC study aims to investigate whether a radiotherapy technique (called Stereotactic Ablative Body Radiotherapy or SABR) can improve outcomes for people with early stage liver cancer compared to other current treatments. Currently, what treatment patients with early stage liver cancer are offered vary in individual circumstances but include; • Radiofrequency ablation (RFA) or microwave ablation (MWA) that use heating probes directly inserted into the tumour to kill the cancer cells. • Transarterial chemoembolisation (TACE) or transarterial radioembolisation (TARE) that uses chemotherapy or radioactive particles injected into the blood supply of the tumour to kill the cancer cells. • SABR is a highly precise radiation therapy technique that uses high energy x-rays focused on the tumour to kill the cancer cells. Who is it for? People who are 18 years of age or over AND have been diagnosed with primary hepatocellular carcinoma (single lesion with the largest diameter equal to or less than 5 cm), AND have not received any prior treatment for this. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. - Patients in Group 1 will receive radiation therapy using a technique called Stereotactic Ablative Body Radiotherapy (SABR) that will be delivered in 3 or 5 outpatient treatment sessions (each 20 to 45 minutes in duration) spaced out over 1 to 2 weeks. The exact number of treatment sessions received, and the duration of each session depends on the size and location of the liver cancer. - Patients in Group 2 will receive standard of care treatment (SOC) as per their institution's local practice that will be administered by a doctor called an Interventional Radiologist. The therapies offered will depend on the size and location of the liver cancer and may include one or a combination of radiofrequency ablation (RFA) / microwave ablation (MWA) and/or transarterial chemoembolization (TACE) / transarterial radioembolisation (TARE). This may require an anaesthetic and an overnight admission to the hospital. Regular follow-up visits will be scheduled at 4 weeks post-treatment and then 3 monthly intervals for 2 years and then 6 monthly until completion of the trial. The same procedures will be repeated but also include imaging; CT or MRI of the liver, blood tests, clinical assessments and a questionnaire on the patient's health status (collected 6 monthly until completion of the trial).

People in high-risk occupations, such as those in emergency service organizations, are at high risk of psychological disorders. Posttraumatic stress disorder (PTSD) is the most common psychiatric disorder that develops following exposure to a traumatic event, and emergency service personnel have markedly higher rates of PTSD. PTSD is characterised by severe and persistent stress reactions including: intrusive memories and nightmares of the trauma, hypervigilance, difficulty sleeping, emotional withdrawal, pervasive negative emotions, and avoidance of places, activities, and situations that are reminiscent of their trauma. The treatment of choice for posttraumatic stress disorder (PTSD) is trauma-focused psychotherapy. Trauma-focused psychotherapy typically commences with psychoeducation about the trauma responses, and then focuses on three major strategies: anxiety management, exposure, and cognitive restructuring. Despite support for this therapeutic approach, meta-analyses indicate that at least one-third of patients do not respond to this treatment. This situation is also evidence in treatment of PTSD in emergency service personnel. One recent advance has shown that training people to retrieve positive memories of their past can alleviate both PTSD and depression symptoms. Accordingly, this trial aims to augment TF-CBT for PTSD by comparing standard TF-CBT with TF-CBT combined with memory training. It is hypothesized that the augmented TF-CBT that includes positive memory training will result in greater reduction of PTSD and depression than standard TF-CBT.