ANZCTR search results

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.

The aim of this pilot study is to obtain data regarding the safety and tolerability of tirzepatide 15mg subcutaneous injection weekly for the treatment of obesity in adults with ESKD. Adults on haemodialysis with a BMI of 30kg/m2 or above who are potential candidates for kidney transplant will be recruited. All participants will receive tirzepatide once weekly, starting at a dose of 2.5mg and increasing every 4 weeks to a maximum dose of 15mg. Participants will receive tirzepatide treatment for a total of 24 weeks.

Study details This registration is for Step 1 of a 2 step study investigating CNT201. CNT201 is a recombinant collagenase product being developed by the Sponsor, which is being studied for the treatment of Dupuytren’s Contracture (DC) This is an adaptive clinical study design containing 2 steps (Dose escalation and Dose expansion). Step 1 (dose escalation) uses an open-label design. Participants will be enrolled to a dose cohort with the CNT201 dose to be administered determined by the cohort to which the participant is enrolled; Afte a screening period of upto 30 days, eligible participants will be enrolled into 1 of 4 cohorts (provisional 5th cohort) and will be administered a single dose of CNT201 at 1 of 4 CNT201 dose levels: First-, low-, intermediate-, or high-dose (Cohort 1 to Cohort 4, respectively) within a treatment cycle. The treatment period will consist of an intralesional injection of CNT201 (Day 1), followed by a series of safety, efficacy, PK, and immunogenicity evaluations for 28 days (until Day 29) with primary efficacy assessed on Day 29 with an additional 28 days of safety follow-up thereafter (until Day 57). If there are no safety concerns on Day 57 as assessed by the investigator, Day 57 will serve as the End-of-Study (EOS) visit for Step 1. Cohort 1 will enroll 4 participants; all other cohorts will enroll 8 participants.

Disorders of Brain Gut Interaction (DGBIs) are extremely common affecting up to onein three Australians. These conditions are chronic, resulting in reduced quality of life for patients and are responsible for substantial health care utilisation. This is largely due to the fact that routinely available treatments do not provide the required symptom relief and long-term improvement of quality of life. In recent times, small intestinal dysbiosis has been identified as a potential cause for DGBI. Small intestinal bacterial dysbiosis refers to an expansion of unfavorable or harmful bacteria in the small intestinal tract. While antibiotics such as rifaximin are proven to improve symptoms in patients with DGBI, there are concerns in relation to antibiotic resistance and antibiotics are not suitable for long term treatment. Previous data suggest that simethicone can be beneficial in DGBI patients and our recent in-vitro data reveal a suppression of growth of bacteria obtained from the small intestine. Thus, we aim to conduct a randomised placebo-controlled trial to test the readily available (over the counter) treatment Simethicone as a means to target the imbalance of bacteria lining the small intestine in patients with DGBI.