ANZCTR search results

The purpose of this project is to assess the acceptability and feasibility of a remote stepped care treatment for individuals with obsessive-compulsive disorder. After assessment all participants will commence clinician-guided cognitive-behavioural bibliotherapy (BCBT) for 8 weeks. Participants who do not meet the predefined response criteria (YBOCS reduction of greater than or equal to 25% and a CGI-I score of less than or equal to 3) will then complete 8 sessions of internet-videoconferencing cognitive-behavioural therapy (VCBT) with a psychologist.

This pilot study will investigate the use of a new knot-free skin closure technique for caesarean section skin wounds. By using this new method to close the skin wound, the researchers aim to reduce the risk of post-operative wound infections and improve patient comfort, whilst also providing surgeons with an easy and reproducible skin closure technique. Currently, a surgical knot named an ‘Aberdeen knot’ is placed beneath the skin at the end of a running stitch during the skin closure at caesarean section. Unfortunately, patients have reported discomfort from the bulky nature of this knot and the bulky knot also increases the risk of wound infection and wound breakdown. Participants will have the proposed skin closure technique performed at the time of their caesarean section and will then be monitored post-operatively by the midwifery and medical staff at Frankston Hospital. Participants will also be required to submit serial photographs and short questionnaires as means of follow-up. This will allow for appropriate monitoring for any wound complications, such as wound infection or wound breakdown. The researchers hope to prove that this knot-free skin closure technique is safe for use in closing the skin wound during caesarean section. Should this small initial study prove to be safe and of good design, a larger randomised trial will be commenced.

This study aims to look at measures of disease activity in ulcers (Pyoderma Gangrenosum) and the potential of response to a new therapy, Tildrakizumab, an injection which is administered under the skin every 4 weeks, for a total of 12 weeks. We intend to perform an exploratory analysis for potential biomarkers of disease activity in Pyoderma Gangrenosum (PG). Our proposal would include an open-label study with 12 weeks of treatment with Tildrakizumab in line with the published dosing frequency for Hidradenitis Suppurativa (200mg Week 0,4 and 8). Outcome measures are obtained from a recent systematic review of outcome measures used in clinical trials of PG.

The early life microbiome plays a crucial role in immune system development and is associated with various health outcomes later in life. A healthy gut microbiome established in early life can reduce the risk of microbiome-related diseases and promote long-term health benefits. Weaning, the transition to solid foods during early life, particularly complex carbohydrates, is considered a “window of opportunity” for shaping the gut microbiome with its optimal configuration. Introducing prebiotic complementary foods can be an effective strategy for establishing a healthy microbiome during this time. However, the infant gut microbiota at the early weaning stage has limited capability to ferment complex carbohydrates and prebiotic substrates. It remains unclear how and when important carbohydrate fermenting microbes and butyrate producers colonize the infant's gut. To develop an effective and practical strategy for shaping healthy infant gut microbiota, a deeper understanding of the developmental trajectory of gut microbiota and its fermentation ability along with the introduction of solid foods is required.

To establish the (1) effectiveness, (2) cost-effectiveness and (3) acceptability of our machine learning (ML) model compared to usual care in selecting the first anti-seizure medication (ASM). Hypothesis: (1) seizure-free rate at 1 year of treatment with the first ASM will be higher in the machine learning group. (2) quality of life, depression and anxiety will improve more in the ML group, and ML model will be more cost-effective. (3) ML model will be acceptable to patients and clinicians. This is a multicentre randomised controlled trial (RCT) across all six states of Australia. Adults will be randomised 1:1 to ML Group (ASM recommended by the ML model) or the UC Group (ASM selected by the neurologist) and followed for 12 months. A sample size of 234 (including 10% dropout) participants will allow for measure of a minimum absolute difference of 20% in 1-year seizure-free rate on the first ASM between the study group (55% ML vs. 35% UC).

Anxiety and depression affect > 3 million Australians, at a cost of over $12.8 billion/year. Without proactive treatment, these disorders can result in chronic disability, illness, low workforce participation, impaired relationships, self-harm, and suicide. Digital mental health interventions (e.g., online cognitive behavioural therapy [CBT]) are effective, and cost-effective treatments for depression and anxiety, achieving similar outcomes to face-to-face therapy and pharmacotherapy. Most importantly, they improve the accessibility, quality, and standardisation of mental health care. Despite this evidence, they have poor uptake and limited use in routine care settings (e.g., private practice). Evidence indicates that blended digital and in-person treatments are preferred by practitioners over digital-only treatments, and reduce treatment length, sessions, and costs compared to face-to-face only treatment. Based on this evidence, along with knowledge about barriers and facilitators of implementation gained via extensive consultation with health professionals and end-users with lived experience of depression and anxiety, we have developed a new blended model of mental health care that integrates leading evidence-based digital interventions with in-person (and/or telehealth) therapy for depression and anxiety. This blended model of care comprises a smartphone application that clients use throughout the course of therapy to enhance therapy skills and provide support between therapy sessions. Psychologists can monitor their clients’ symptoms via a purpose-built Health Professional Portal and tailor their treatment based on their clients’ progress. The aim of this study is to evaluate the acceptability, feasibility and preliminary effectiveness of this new blended model of care in the context of psychological therapy for adults with depression or anxiety. Implementation barriers and facilitators, as well as outcomes at the client, psychologist, and practice level will be evaluated. The findings from this study are expected to generate new knowledge that will help to improve the uptake, use and sustained implementation of digital interventions for depression and anxiety in routine psychological therapy. In doing so, we hope to increase the quality of care provided to patients, and ultimately improve patient outcomes.

Research has shown that first responders, including police officers are more vulnerable to experiencing stress-related conditions due to the nature of their work. Studies have also shown that hyperarousal is a common symptom associated with work-related stress, and mental health problems such as posttraumatic stress disorder (PTSD), anxiety and mood disorders. Specifically targeting the management of hyperarousal in therapy programs may be useful to helping police officers experiencing hyperarousal symptoms. The primary aim of this study is to investigate the feasibility and effects of a newly developed de-arousal therapy program in managing hyperarousal symptoms in NSW police officers. We expect that the therapy program will help officers to reduce their hyperarousal symptoms as well as concurrent stress, anxiety and/or low mood symptoms and improve their general well-being. This is a pilot feasibility study. Therefore, feedback from officers who take part in this study will offer insights into which types of de-arousal strategies are more helpful in managing symptoms and improving well-being. The data from this study will also contribute to enhancing work towards organisational change in the police force.

The primary purpose of this research is to evaluate potential benefits of thickening the soft tissue (gums) that surround dental implants, by placing a soft tissue substitute at the time of implant placement. The application of the soft tissue substitute may minimise the amount of bone loss that occurs following implant placement in the presence of thin soft tissue/gums (known as thin mucosal phenotype). Thin mucosal phenotype is observed when the thickness of the soft tissue (gums) at the planned implant site is 2mm or less. It has been demonstrated that a minimum thickness of the gums is required around dental implants, if this is not present loss of bone may occur around the shoulder/collar of the implant (the part of the implant closest to the surface), This occurs to accommodate an increase in thickness of the gums. This study is evaluating the differences in marginal bone level changes which occur in the first 12 months after the implant is restored (a crown is placed on the implant), in sites which receive a soft tissue substitute at the time of implant placement (group 2), compared to sites which receive implant placement alone (group 1- this is the usual treatment approach). Study participants will be randomised to one of these treatment groups.

The research project is testing a new imaging/treatment device for use during breast conserving surgery, involving the use of a medical device called ORM-P2 System. The purpose of this study is to find out if it is safe to use the ORM-P2 System during breast conserving surgery for patients with breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, you have been diagnosed with invasive or in situ breast cancer and you are eligible to undergo breast conserving surgery as part of your cancer treatment. Study details All participants who choose to enrol in this study will be asked to attend three study visits scheduled over a 4 month period. The first visit will be a screening visit to determine whether you are eligible to enrol in the study. Those participants who are eligible to enrol will continue with their standard cancer care and will be scheduled for a breast conserving surgery. The surgery will be undertaken per standard protocols, with the addition of the ORM-P2 medical device. During the surgery, a clinician will use the device to scan the breast tissue. The device will provide images on the tissue's optical and mechanical properties on a micro-scale. Use of the device is anticipated to add 5 to 10 minutes to the overall surgery time. At 4 weeks after the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken. It is hoped this research will determine whether use of the ORM-P2 System is effective at differentiating tissue types remaining in the surgical cavity.

In postmenopausal women, the follicle stimulating hormone (FSH) is elevated. Elevated FSH has been shown to accelerate aging, as high FSH leads to decreased bone mass, reduced muscle mass and increased fat mass, as well as to increased risks of diabetes, metabolic syndrome, kidney dysfunction, heart disease and Alzheimer’s disease. ALG-801 has been designed to block certain proteins within the transforming growth factor-beta (TGF-ß) family, including activin A and activin B, which stimulate FSH release. By blocking these proteins that control the release of FSH hormone, the effects of elevated FSH on bone loss, muscle atrophy, fat accumulation and insulin resistance may be reduced. This clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of ALG-801 in healthy postmenopausal women who meet the eligibility requirements. This study is a multiple ascending (increasing) dose study where approximately 32 participants will be randomized to receive 4 doses of the study drug or placebo over a period of 4 weeks. The primary objective of this study is to establish safe dose levels of ALG-801 in healthy postmenopausal women following multiple dose administration, and secondarily to evaluate the influence of ALG-801 on biomarkers of bone turnover and muscle mass.