ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

You can narrow down the results using the filters

30806 results sorted by trial registration date.
  • The effect of Produce Prescription on health among adults with type 2 diabetes – a randomised controlled trial

    Unhealthy dietary patterns including high intakes of sodium, refined carbohydrates, processed and red meat, and low intakes of fruits, vegetables, wholegrains, nuts and legumes, and fibre are leading risk factors for noncommunicable diseases such as type 2 diabetes. Eating a healthy diet is fundamental to the management of type 2 diabetes, but this can be particularly challenging for those who struggle with food security. Current clinical practice based on providing dietary counselling alone is inadequate if individuals are unable to access and prepare the foods and meals recommended. ‘Food is Medicine’ programs aim to integrate nutrition interventions into the health care system to help improve the clinical population’s diet and complement pharmacologic treatment of diseases. ‘Produce prescription’ (Produce Rx) is one such approach, in which healthy foods are subsidised or provided free-of-charge to patients as part of a health care intervention. We will therefore conduct a randomised controlled trial of produce prescription in adults with type 2 diabetes (T2D) and ongoing hyperglycaemia who experience food insecurity, recruited from diabetes centres in large hospitals and General Practices (GP) in New South Wales, Australia, and through a community advertisement. As part of the intervention package, participants will receive produce prescription (a healthy food box delivered to their homes) and be provided with dietary consultations to encourage uptake of foods and support enhancement of the overall healthiness of their diets. Our goal is to investigate a real-world pragmatic produce prescription intervention that will be feasible to embed in the Australian healthcare system. We are testing a primary null hypothesis of no difference in the HbA1c between participants in the intervention (receiving produce prescription) and control group (usual care) over 26 weeks.

  • Optimising patient positioning for accelerated partial breast radiotherapy with the Integrated Magnetic Resonance Linear Accelerator

    The aim of this study is to compare the benefits and limitations of different positioning options for early breast cancer patients who are suitable for partial breast treatment on the Magnetic Resonance integrated Linac. Who is it for? You may be eligible for this study if you are a female age 40 or older, with early stage breast cancer and suitable for accelerated partial breast radiotherapy. Study details Participants will receive both a supine (on your back) and prone (on your tummy) scan in the MRI and a CT scan in the ideal treatment position (supine OR prone) as per our usual standard of care. Participants will then be asked to complete a short (10-15 mins) anonymous survey on an electronic platform to ask about their experience of the MRI scan and whether they have a preference for the supine or prone position. There are no changes to standard treatments for participants. It is hoped that the findings from this study will streamline the simulation process for APBI patients and help us to determine who would benefit from which position without needing to complete both scans. It is also hoped that this information can be used across our other treatment machines to benefit patients who may not be able to have an MRI scan to work out the best position for them.

  • Treatment of functional gut symptoms in patients with quiescent inflammatory bowel disease and irritable bowel syndrome - A single-blinded parallel trial assessing efficacy of app-delivered gut-directed hypnotherapy versus psychoeducation

    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.

  • A Randomised Feasibility Trial Examining the Use of Music Therapy Informed Strategies During Dementia Care on Professional Caregivers in Residential Aged Care Facilities

    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.

  • Comparison of two different surgical techniques for the treatment of recurrent atrial fibrillation after initial catheter ablation.

    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.

  • FOOT-C: Foot Ulcer Treatment with vitamin C.

    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.

  • The Mind, Heart, and Spine (MHS) Study: the effect of biofeedback for treating pain and mental health in adults with spinal-related disorders.

  • Feasibility of a Digital Coach for Self Esteem.

    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.

  • KATRINA: Pembrolizumab (KeytrudA) in early Triple Negative breast cancer in Australia

    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.

  • Investigating the management of allergy with amino acid-based formula and synbiotics in Australian infants with cow’s milk allergy

    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.

Tags:
  • Finding clinical trials