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Pilot study in fibroblast activation factor expression in lung graft versus host disease (GVHD) following haematopoietic stem cell transplant (HSCT)
Expand descriptionThis study aims to assess if it is feasible and accurate to use a novel PET scan to identify pulmonary Graft Versus Host Disease (GVHD) following haematopoietic stem cell transplant (HSCT) for blood cancers earlier than conventional and invasive testing. Who is it for? You may be eligible for this study if you are an adult allogeneic HSCT recipient at Royal Brisbane and Women's Hospital, with an existing diagnosis of pulmonary cGVHD (bronchiolitis obliterans syndrome [BOS], cryptogenic organising pneumonia [COP], or interstitial lung disease [ILD]). Study details Participants will undergo a single 68-Ga Fibroblast Activating Protein Inhibitor (FAPI) scan, as well as other testing modalities such as spirometry, high resolution CT scan and clinical questionnaires. These modalities will be compared against each other to determine the ability of the FAPI PET scan to detect lung scarring in pulmonary GVHD. It is hoped that findings from this study will help researchers develop new and less invasive ways to detect pulmonary GVHD to facilitate earlier management and intervention.
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Assessing the influence of photobiomodulation on inflammatory biomarkers in patients with Temporomandibular disorders
Expand descriptionTemporomandibular disorders (TMD) are a group of conditions that affect the jaw joint (temporomandibular joint), the surrounding musculature, and the nerves related to chronic facial pain. Unlike other TMD therapy modalities photobiomodulation (PBM) is widely regarded for its clinical safety, non-invasiveness, anti-inflammatory and analgesic properties. PBM has been shown to be a beneficial adjuvant when used with other TMD therapies. While photobiomodulation has been reported in several studies to effectively relieve symptoms of TMD, the mechanism of action of photobiomodulation on the early inflammatory biomarkers remains unclear. Furthermore, little is known regarding the impact of how different wavelengths of near infared lasers impact the inflammatory biomarkers in the treatment of TMD. The purpose of this study is to shed light on the dynamics of photobiomodulation via the use of Infared lasers in influencing early inflammatory cytokines, such as TNF-A and IL-1B, in TMD therapy using only patient saliva samples. It is hypothesized that patients with TMD will have reduced levels of inflammatory markers following PBM treatment. This research will be conducted at the School of Dentistry and Oral Health, Griffith University, Gold Coast and at The Thirty Two- a private dental practice located at T28/129 Queen St, Gold Coast.
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A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients with Postherpetic Neuralgia.
Expand descriptionThe primary purpose of this study is to evaluate the clinical efficacy and safety of topical lidocaine spray in reducing neuropathic pain is superiority in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo spray.
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SMS Text Message Support for Motor Vehicle Related Injury
Expand descriptionRoad-traffic injuries are often psychologically distressing; beyond the physical trauma, navigating compensation can heighten feelings of being overwhelmed and lower self-efficacy, which are linked to slower recovery and greater healthcare use. Early, clear information and supportive contact may mitigate distress and improve functional outcomes. Scalable mHealth approaches (e.g., automated SMS) offer a low-cost way to deliver timely reassurance and self-management prompts. This double-blind, two-arm randomised controlled trial (n=254) will test an SMS support program for Allianz NSW CTP claimants. All participants receive usual customer support plus two short videos delivered via SMS links (claims navigation and pain self-management). The intervention arm also receives once-daily supportive SMS for 28 days; the control arm receives the videos only (no SMS). The primary outcome is pain self-efficacy; secondary outcomes include claims satisfaction, pain, psychological distress, return to work, healthcare costs, and feasibility (adoption, engagement/reach, acceptability), assessed post-intervention and at 4 months. We anticipate that participants who receive the SMS text-messages in addition to the videos will feel more confident to manage both their claim and their pain during recovery.
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Assessing the feasibility of non-steroidal anti-inflammatory drugs, benzodiazapines or no intervention in patients older than 60 who are having major surgery
Expand descriptionThis pilot project aims to assess if conducting a study comparing administration of non-steroidal anti-inflammatory drugs, benzodiazapines and no intervention is feasible. The study is being undertaken in patients older than 60 who are having major surgery (not involving the heart or the brain). Study participants will be randomly allocated to one of three treatment groups, non-steroidal anti inflammatory, benzodiazepine or no intervention. Participants will also be asked to undergo delirium assessments for the first 3 post-operative days. If this pilot study is able to be completed with minimal deviations to the protocol and a good participant recruitment rate, a larger study will be undertaken. The larger study will assess the rate and severity of post-operative delirium - a type of temporary confusion and/or agitation that occurs after surgery and is more common in older adults.
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Mental Fitness in the Law: A Resilience Training and Research Program for Legal Professionals
Expand descriptionThis project will evaluate a resilience training program for lawyers. Resilience describes a person’s capacity to “bounce back” from stressful events, such as the workplace stressors experienced by lawyers. Research in some populations indicates that adaptive self-reflection on daily stressors can facilitate the development of resilience. The training program teaches systematic self-reflection, a structured process for examining coping responses to stressful events. The study will involve practising and graduate lawyers across Australia. Participants will attend an initial workshop, complete weekly reflection activities, take part in two short check-in calls, and complete three online surveys over five months. They will be randomly assigned to reflect from either a self-immersed (first-person) or self-distanced (third-person) perspective. The research will test whether reflection perspective influences the development of resilient beliefs and reductions in stress, anxiety, depression, and burnout. Findings are expected to provide evidence for a scalable resilience training approach for the legal profession and advance understanding of how reflective practice can best be utilised to strengthen resilience.
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Do Antibacterial Sutures Help Prevent Infections After Surgery? A Pilot Study in Australian Hospitals
Expand descriptionThe NEWStitch trial is a cluster randomised controlled pilot study comparing Triclosan-coated sutures with non-coated sutures in adult surgical patients. Conducted across four NSW hospitals, the study uses 8-week cluster blocks to simplify implementation and maintain protocol adherence in high-volume operating settings. The primary aim is to assess feasibility for a larger trial, including recruitment rates, data capture, and adherence to randomisation. Secondary outcomes include surgical site infection rates, wound healing (Bluebelle PROM), cost-effectiveness, adverse skin reactions, complications, and readmissions. This independent, non-industry-funded study responds to growing concern about the routine use of Triclosan sutures without sufficient evidence on safety, effectiveness, or cost.
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Sound Asleep: A Novel Approach to Treat Obstructive Sleep Apnoea and Associated Cognitive Impairment
Expand descriptionObstructive Sleep Apnoea (OSA) is a chronic disorder caused by repetitive upper airway collapse during sleep. One aspect of sleep that is critical for effective cognition is the presence of slow wave sleep; a deep, stable phase of Non-REM sleep. It has been found that that individuals with OSA have less slow wave sleep, poorer cognition and brain atrophy compared to healthy individuals. Existing treatments for OSA have a limited impact on cognition and patient acceptance is poor. Direct enhancement of slow wave activity via acoustic stimulation is a new, non-invasive therapy for improving sleep quality and cognition. Preliminary work showed acoustic stimulation in healthy adults enhanced SWA, improved cognition and reduced next-day sleepiness. The current project will test the hypotheses that acoustic stimulation increases SWA, alters OSA pathophysiology, improves cognition, and reduces sleepiness in individuals with OSA.
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Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy (2501/OCOG-2022 ROSALIE) substudy: Assessing the impact of treatment on patient quality of life for adults recruited from Australia and New Zealand
Expand descriptionThe purpose of this sub-study is to assess the impact of radiation therapy on quality of life and patient experience for women with breast cancer. Who is it for? You may be eligible for this sub-study if you are an adult who has been diagnosed with breast cancer and is already participating in the ROSALIE study (NCT05866458 - "Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy"). Study details When you sign consent for the main ROSALIE study, you will have the option to choose to answer some questions about how the cancer diagnosis and treatment affects you. These include: * How you feel about the chance of cancer coming back * How you feel about the results of your surgery, such as how your breast looks, any pain or other feelings, effects on how you can use your arms and shoulders; and * Effects of breast cancer on your physical and mental health. The questionnaires can be completed at home on your computer, tablet or mobile phone, or paper versions can be posted to you. It will take a maximum of 20 minutes to complete all of the questionnaires. You will be asked to complete them 5 times: * When you start ROSALIE (Registration) * 6 months after registration * 1 year after registration * 3 years after registration * 5 years after registration. Your responses will remain confidential. Any concerns should be discussed with your doctor. This part of ROSALIE is optional. You can still take part in the main ROSLAIE study even if you decide not to do the questionnaires. It is hoped that the results of this study will help to inform women with breast cancer when making decisions on the best course of action with their cancer treatment.
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Trialling group improv and acceptance and commitment therapy as a treatment for childhood stuttering
Expand descriptionThis study aims to continue the pursuit of therapy approaches that view the client holistically, and do not just focus on their overt stuttering. This co-designed therapy uses group improv to support clients to positively participate and continuously engage in the activities and social situations that are important to them. Focusing on increasing the awareness of one’s own communication abilities in a risk-free supported environment guided by experts in the field of stuttering has the potential to improve long term outcomes for participants. This project seeks a solution to the lack of affordable, holistic treatment for children and teens who stutter, who are at great risk of inequitable outcomes throughout their lives. An approach that combines group work, improv and acceptance and commitment therapy has great potential to improve their quality of life. We hypothesise that following the improv group, children and teens will have increased social participation, increased communicative confidence, and reduced anxiety levels.