ANZCTR search results

This study aims to assess the anti-tumour activity, safety, and interactions of single-agent SL-28 as an anti-cancer treatment in patients with a diverse array of solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced solid tumor, including head and neck cancer, small-cell lung cancer, non-small cell lung cancer; mesothelioma; oesophageal cancer, gastric cancer, liver cancer, colorectal cancer, pancreatic cancer, bladder cancer, kidney cancer, prostate cancer, ovarian cancer, endometrial cancer, breast cancer or skin cancer (melanoma) that is locally advanced, metastatic or unable to be surgically removed. Patients will also be assessed by a study doctor to ensure that they are well enough to participate in the trial before they will be offered enrolment into the study. Study details All participants who choose to enroll in this study will receive 12 weeks of SL-28 treatment, administered on a 5-days-on, 2-days-off schedule. The first group of participants to receive SL-28 will be monitored for 12 weeks before a second group may be administered a higher dose of SL-28. Up to three cohorts will be enrolled to determine the highest safe and effective dose that does not cause severe side effects in patients. It is hoped this study will show that SL-28 is safe to deliver to patients with solid tumour cancers, and determine the highest dose of SL-28 that cancer patients can safely receive.

Sleep is regulated via a homeostatic need for sleep and circadian biology, which is now well understood to involve light-sensory neuro-hormonal signalling to intracellular clock mechanisms throughout the body. Despite major advances in the mechanistic understanding of the body-clock system, practical methods for daily circadian tracking do not exist. This pilot trial aims at testing and refining the first high performance hybrid wearable-sensor integrated with circadian physiology and data driven analysis methods needed for daily circadian rhythm tracking in healthy adult sleepers and adults with sleep disorders. Participants will be wearing wrist-, chest-, and neck-worn monitors, and using a mattress and bedside sensor and monitoring device, to capture a range of physiological signals, such as skin and core body temperature, physical activity, heart rate, and ambient light exposure data in 3 days (72 hours). They will also be ingesting capsules which contain a temperature sensor and a wireless transmitter to record core body temperature (about 1 capsule ingested per day). Data generated will be used to refine current analytical methods to separate small circadian from much larger activity and exercise effects on core body temperature.

Heavy menstrual bleeding (HMB) in women of childbearing age on anticoagulation is likely under-reported, but is a significant issue. Studies to date suggest that oral factor Xa inhibitors may be associated with a higher risk of HMB than direct thrombin inhibitors, and that dabigatran is likely to be associated with less HMB than apixaban, however more data is required to confirm this. If a particular class of anticoagulant can be demonstrated to have a lower incidence of HMB, then this could be useful to guide clinicians as to which anticoagulant to use in women of childbearing age requiring anticoagulation, particularly those who have pre-existing issues with HMB. We aim to prospectively collect data on women of childbearing age on anticoagulation for VTE (venous thromboembolism), recording their menstrual bleeding both at baseline and after six months of anticoagulation. We will compare HMB rates on dabigatran and apixaban. The data on apixaban will be collected mainly from our collaborating centre/s in the UK and Australia, as apixaban is not funded for VTE in NZ.

Anxiety associated with medical procedures is common, with 40-80% of children experiencing significant symptoms and postoperative consequences, including distress and delirium, increased intensity/duration of pain, prolonged hospital stays, behavioural/sleep disturbance and avoidance of medical encounters, which often remain into adulthood. Extensive consumer research has shown that a key priority for Australian consumers of all ages in relation to paediatric hospital care is addressing the fear and anxiety in children throughout the hospital experience (second only to anaesthesia safety for adults and third following anaesthesia safety and pain management for children). The STARFISH trial was driven by our consumer partners, particularly our youth consumers. It is well known that distraction is a coping strategy that can help with perioperative anxiety, and all members of the perioperative team commonly employ distraction techniques with patients during routine clinical care. One potential form of distraction involves sensory activities - fidget devices or sensory toys such as spinners, putty, and stability balls are increasingly being used within school settings to help students academically and behaviourally, with applicability for neurodiverse (e.g., autistic, Attention Deficit Hyperactivity Disorder (ADHD)) children being one area of particular interest. However, the research behind sensory toys is inconclusive. Sensory toys have been suggested to our team—from numerous consumers of all ages, including neurodiverse and neurotypical consumers—as a method to reduce anxiety in the preoperative period, thus leading to the design of the STARFISH trial. This project aims to assess the use of a sensory toy (of the child’s choice) in the perioperative period on the day of surgery to reduce perioperative anxiety and distress.

The gut microbiome plays a pivotal role in modulating gastrointestinal function, emotional well-being, sleep quality, and immune responses through complex bidirectional communication within the microbiota-gut-brain axis. Disruptions in gut microbial composition have been associated with digestive discomfort, altered bowel habits, psychological distress, and sleep disturbances. Emerging clinical evidence supports the potential for targeted probiotic interventions to improve these symptoms by restoring microbial balance and modulating neuroimmune pathways. This randomised, double-blind, placebo-controlled trial will investigate the effect of low and high-dose Lactiplantibacillus plantarum BMB18 (DSM 35214) supplementation in improving digestive function over six weeks compared to placebo, with a follow-up at eight weeks. This trial will also investigate the effects of the dietary probiotic supplement on self-reported indicators of quality of life, sleep quality, and mood, such as depression, anxiety, and stress. The present study will recruit healthy male and female adults aged between 18 and 65 years who report mild digestive symptoms and/or occasional sleep or mood disturbances without a diagnosis of any major gastrointestinal or psychiatric disorders (e.g. IBS or MDD). The outcomes of this trial will broaden the literature on the promising potential of probiotic supplementation by characterising clinical benefits and generating translational evidence for future trials as the first study examining the effects of L. plantarum BMB18 in humans.

Healthier Wealthier Families (HWF) is a partnership between Queensland Health, UnitingCare Queensland, the Australian Research Alliance of Children and Youth, and academia, that aims to reduce financial hardship and improve the mental health of caregivers with young children. Through the first randomised trial of its kind, HWF will connect universal Child and Family Health Services (well-child health care delivered via home visits) with financial wellbeing services in Queensland, and evaluate the benefits and costs, and opportunities for scaling nationally.

This study aims to investigate the effect of early oral feeding (initiated within 5 days post-surgery) in comparison to traditional postoperative care involves withholding oral feeding for 7–12 days, in free flap reconstruction after head and neck cancer resection. Who is it for? Participants will be adults, who have undergone an intra-oral cancer resection who require a free tissue transfer for reconstruction and have not undergone previous radiation. Study details Patients will be randomised to either standard feedings (diet introduced at day 7 postoperatively) or early feeding (diet introduced day 1 postoperatively). Pre-operative and post operative swallowing assessments will be done by speech pathology. Data will also be collected on key outcomes such as nasogastric tube removal, days spent in hospital, and complications. It is hoped that findings from this study will help researchers and clinicians determine if early oral feeding offers benefits in terms of reduced hospital stay and faster recovery.

This study is a pilot randomised, placebo-controlled clinical trial to determine the effects of a single dose of two amino acids L-theanine and L-Glycine (The-Gly) on resting cardiovascular responses in postmenopausal women. This study involves two visits, one for the measurement of baseline parameters and second visit for the intervention and 60 minutes and 120 minutes follow up.

Initial treatment of snake bite involves early first aid with the application of a pressure bandage and immobilisation (PBI) of the limb. There is limited data to support the basis of this technique and emerging evidence of harm when applied incorrectly. This project sets out to evaluate PBI compared to another technique involving the application of a pressure pad (PP) at the bite site (which is easier to do, and used in most countries outside of Australia), The project aims to determine whether each technique is effective, and whether the PP technique is at least as effective as PBI. To do this 24 participants will be recruited to undergo study with mock venom injected into their hand or foot and having either PBI or PP applied. The mock venom will then be traced with a gamma camera to determine rate of flow through the lymphatic system, which is how venom travels in the body. It is expected that the project will demonstrate the efficacy of both techniques, and that the PP will be at least as effective as PBI. This will provide a basis for change in the current first aid recommendations for snake bite first aid in Australia, and improve the care provided.

This study will explore the efficacy of the mobile health app, cpThrive. Families of children with CP will participate in the study, using cpThrive for 12 months to explore whether this improves health knowledge and impacts function. cpThrive is a mobile app that has been co-designed with people with lived experience, to provide people with cerebral palsy and their families with up to date information on intervention options. cpThrive allows users to search interventions that are relevant to their age, functional ability and current goals and priorities. It includes fact sheets and real-life video examples of interventions. cpThrive aims to improve access to health information, which may in turn lead to improvements in function and participation.