ANZCTR search results

The treatment of inflammatory bowel disease (IBD) primarily involves targeting inflammation with pharmacological agents, but comorbidities, including functional gut symptoms (DGBI), are common and poorly defined within this population. DGBI diagnosis in IBD is challenging due to confounding factors and reliance on symptom-based criteria. Current assessment methods, such as clinical remission evaluation and biochemical markers, may not accurately identify DGBI in the absence of inflammation. Advances in assessment include intestinal ultrasound for detecting ongoing disease activity and identifying patients with increased intestinal permeability, potentially aiding in distinguishing functional gut symptoms from inflammation-associated symptoms. Limited evidence exists for efficacious treatments for DGBI in IBD, with a notable exception being a trial supporting the use of a low FODMAP diet for symptom relief in patients with quiescent disease. Gut-directed hypnotherapy (GDH) emerges as a potential therapy to reduce symptom burden, offering efficacy comparable to in-person sessions and superior to psychoeducation. However, research on GDH efficacy specifically in patients with truly quiescent IBD is still ongoing.

MATCH is an eHealth solution, “Music Attuned Technology Care via eHealth,” developed to support carers of people living with dementia to use music intentionally to support care. It is a scalable solution for the growing number of people living with dementia. We developed the ‘MATCH Music Training Program’ as part of this package, which we will trial 2 MATCH interventions in residential aged facilities in this feasibility study to inform future powered trials.

The purpose of this study is to ascertain whether more extensive ablation for Atrial Fibrillation is more effective than limited ablation. We hypothesise that more extensive ablation will be more effective.

Vitamin C plays an important role in wound healing and half of patients with diabetes-related foot ulcers (DFU) are reported to have low vitamin C levels. There is a strong association between low vitamin C levels and high levels of amputation in people with DFU. Furthermore, small studies have recently reported vitamin C improved the wound healing of foot ulcers. Therefore, the aim of this study is to determine if consuming an oral vitamin C supplement can improve wound healing in people with DFU. The outcomes of this clinical trial will provide the first strong evidence as to whether vitamin C supplementation can improve the healing of DFU and whether it will be helpful to prevent some of the 4,400 amputations annually in Australia.

A spinal-related disorder (SRD) refers to any condition that affects the spinal column and surrounding structure. Some common SRDs, include degenerative disc disease, disc herniations, spinal stenosis, scoliosis, arthritis of the spine, spondylolisthesis, and tumors. These disorders typically result in chronic pain, mental health issues, severely impacting on daily life, functioning, and overall quality of life. Current treatments for chronic pain in SRD populations include anti-inflammatory, diets, physical activity, cognitive behavioral therapy, electrical stimulation, each with varying degrees of success. However, little research has been done on heart rate variability feedback and paced breathing (HRV-F), a promising low-cost, self-regulation, non-invasive intervention that could alleviate pain and improve mental health and well-being. This study will assess the effectiveness of HRV-F in improving pain and mental health in adults with SRDs. The hypothesis is that adults with SRDs who receive HRV-F intervention will experience greater improvements in pain levels and mental health compared to when they receive standard care alone.

The aim of this research project is to investigate the feasibility, usefulness and applicability of a digitally delivered low intensity psycho-educational tool to increase the self-esteem of participants. The psycho-education will be delivered by an embodied conversational agent, known as HAFSE (Helper Agent For Self Esteem). Students often suffer from low self-esteem and are thus a suitable population. HAFSE is intended to help students improve their SE, but we also anticipate that students with even average levels of self-reports SE scores may still benefit from the conversations. As a feasibility study we also seek to assess the usability of the tool and the user's experience. Thus, we do not screen participants based on their level of self esteem and intend to examine whether baseline levels of SE influence the results. We will measure participant self-esteem and self-efficacy before and after interaction with HAFSE.

This study aims to collect data related to patient and disease characteristics, treatment patterns and outcomes of early triple negative breast cancer (TNBC) patients, who have received pembrolizumab in the neoadjuvant setting via a medicine access program or reimbursed supply in Australia. Who is it for? You may be eligible for this study if you a patient of any age, gender with high risk, early stage TNBC who are enrolled in the pembrolizumab access program or accessed pembrolizumab via the PBS are eligible for enrolment to the study. You will not be required to undergo any additional tests or assessments for this study. We will be collecting your data captured as part of routine care from medical records. The study will enable collection of comprehensive, real-world data of patients with early triple negative breast cancer receiving pembrolizumab to improve understanding of the disease presentation, treatment patterns and patient outcomes in routine clinical practice in Australia. The protocol and relevant supporting information will be submitted to Human Research Ethics Committees (HREC) and/or the respective Research Governance Officer (RGO; if required) and approved by the HREC and/or the respective RGO before the study is initiated.

This study will follow infants diagnosed with cow's milk allergy as they are prescribed a commercially available amino acid formla. The formula contains a combination of prebiotics (short chain galactooligosaccharides and long-chain fructo-oligosaccharides), probiotics (Bifidobacterium breve M-16V) and human milk oligosaccharide (2'Flucosyllactose). The aim is to generate local real-world evdience on the effectiveness of the formula based on parent-reported and investigator-reported outcomes questionnaires and infant microbiota profile. The hypothesis is that the formula would improve overall allergy symptoms.

The primary purpose of this study is to describe progression-free survival for patients with stage I-II follicular lymphoma treated with radiotherapy alone compared with radiotherapy plus immunotherapy. Who is it for? The registry will collect information on patients with stage I-II low grade follicular lymphoma treated with curative intent radiotherapy after staging, who received either no additional therapy or systemic therapy containing immunotherapy as part of planned combined modality therapy. Study details: Eligible patients will be identified using local patient databases, and local medical records will be reviewed. Information on demographics, staging procedures (bone marrow, CT, PET imaging), disease characteristics including WHO tumour grade (1-3b) and extranodal site, radiation treatment delivered (RT dose and method, e.g. IFRT, Involved Site RT(ISRT)), systemic therapy delivered (immunotherapy details if given and other systemic therapies if given) and follow-up information will be collected and contained within a RedCap database. It is anticipated that in coming years, new cohorts of patients with stage I-II follicular lymphoma treated with immunotherapy will become available for inclusion and that outcomes for existing cohorts will be updated. For this reason, a registry will be established, both to enable research to be conducted on retrospectively acquired data from cohorts of patients already documented and to enable updated outcome data to be uploaded for these existing cohorts. The registry will also accommodate new patient cohorts as they become available as immunotherapy becomes more widely used. Hence the registry will ultimately include a combination of retrospective and prospective elements. The registry's utilization can contribute to demonstrating the efficacy of systemic therapy in reducing the risk of death or progression and informing therapeutic decisions to enhance health outcomes in managing follicular lymphoma, where immunotherapy's historical underutilization in stage I-II FL has resulted in a lack of notable improvement in overall survival.

Children commonly display restless and irritable behaviours (known as emergence delirium (ED)) when awakening from general anaesthesia. Usually this is a short-lived and self-limiting problem however it can cause harm if wounds are disrupted, or intravenous lines are dislodged. Additionally, it can be distressing for parents and carers. Ways of reducing the risk of ED have been investigated but none has been shown to reliably prevent it from occurring. Some risk factors are known (for example, younger age, male sex, particular types of anaesthesia and surgery). The microbiome offers a potential insight into various psychological and behavioural conditions, and we wonder whether this might also be the case for ED. If particular microbiome profiles can be associated with different risk profiles and identified in advance of exposure to general anaesthesia, then perioperative management may be altered to reduce the risk of ED.