ANZCTR search results

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

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32971 results sorted by trial registration date.
  • Plant-based and Animal-based Protein Diets on Muscle Growth and Functional Health in Overweight Elderly - Feasibility study (Phase 2)

    AIM: The overall aim of the feasibility study is to investigate the effect of a plant-protein and animal-based diet on healthy ageing. OBJECTIVES: 1) The primary objective, in the context of preserving musculoskeletal health as a key component of healthy ageing, is to assess the effect of plant-based and animal-based protein-source diets on muscle fractional synthesis rates in overweight elderly over time. 2) The secondary objectives, aligned with broader determinants of healthy ageing, are to evaluate the difference in plant-based and animal-base protein-source diets on metabolic function (inflammatory markers, glucose variability and lipid profile), cardiovascular outcomes (vascular function and stiffness), feasibility, acceptability and compliance, dietary composition (macronutrients/micronutrients/amino acids/dietary protein quality), and greenhouse gas emissions (life cycle analysis). 3) The exploratory objectives are to evaluate differences in plant-based and animal-based protein-source diets on chemical and activity-based biological ageing markers (proteomic, metabolomic, lipidomic, and physical activity). This study addresses the knowledge gap on the real-life effects of a plant- and animal-protein whole-food diet on muscle protein synthesis and functional health outcomes in elderly and may lay the foundation for more extensive research. The study can guide sample size calculations, methodology, and feasibility of future intervention studies in the same field. The study can help find barriers and refine strategies to reach the target group. Findings may further help guide recommendations for protein intake in the elderly population, and help understanding of the biological mechanisms of the global transition to a more plant-based protein-source diet in the elderly population. Investigation of the exploratory outcomes can help generate hypotheses to inform future research, by providing insight into how molecular pathways affect healthy ageing, thereby supporting the primary aim

  • Assessing the effect of ketamine on disruption of memory reconsolidation in Post Traumatic Stress Disorder

    This study is pioneering in its investigation of ketamine for the treatment of Post Traumatic Stress Disorder (PTSD). We will do this by reactivating traumatic memory via a short writing task. Ketamine will then be administered following the retrieval of these unpleasant, traumatic memories. When a stored memory is reactivated, it may transition from a consolidated state to a more malleable one, where its content or meaning can be modified. This altered memory is then re-stored through a process called reconsolidation. This mechanism is particularly relevant to PTSD, as theories suggest that the disorder is connected to the processes of fear learning and memory updating. Theoretically, by pharmacologically disrupting this reconsolidation process with ketamine, specific memories can be selectively weakened. This temporary window of memory instability following reactivation provides a novel opportunity to directly alter trauma-related memories and reduce their potential to trigger relapse.

  • Testing a new lightweight brain scanner (the Micro-X Stroke Scanner) for detecting brain conditions that affect stroke treatment decisions in hospitalised patients.

    Brief description of the study purpose This study is testing a new portable brain scanner, called the Micro-X Stroke Scanner (MXS), to see whether it can reliably detect brain conditions that would prevent clot-busting treatment for suspected stroke, compared with a standard hospital CT scan. Who is it for? You may be eligible for this study if you are aged 18 or over and admitted to hospital with a known brain condition seen on imaging (such as stroke, brain bleeding, or brain tumour), or if you have stroke-like symptoms but a normal brain scan, and you are already clinically suitable for a CT brain scan. Study details Participants will have one scan with the Micro-X Stroke Scanner, in addition to their routine hospital brain CT scan. There is no randomisation; all participants receive both scans, and the new scanner will not be used to guide their medical care. The brain images from both scanners will be reviewed independently by multiple specialist readers to compare how well the two scanners detect important brain findings. It is hoped that the results from this study will support the future use of portable brain scanning in ambulances or remote settings, which could improve access to timely stroke treatment, particularly for people in regional and rural areas.

  • Testing the feasibility of Living Well after Hospital: A coordinated care program for older adults returning home after hospital

    This study will explore the feasibility and acceptability of the Living Well after Hospital program for frail older adults leaving hospital, and the feasibility of a future randomised controlled trial to test the effectiveness of this program in increasing time spent living in the community after leaving hospital. Findings from the feasibility study will be used to refine the Living Well after Hospital program and study procedures ahead of the randomised controlled trial. Forty patients and their support persons from three general medical and geriatric medicine wards at the John Hunter Hospital will receive the Living Well After Hospital program for 60 days after leaving hospital, comprising a dedicated Living Well nurse, targeted education, routine follow-up calls, and active linking with the patient's GP. Participants will be sent a follow-up survey 30 days after leaving hospital. Interviews will be completed with a selection of participants and Living Well nurses to further explore the feasibility and acceptability of the intervention. It is expected that the intervention will be feasible and acceptable to participants and project staff, and that the recruitment and data collection methods for the randomised controlled trial will be feasible.

  • Mapping men's health systems use in Australian general practice: a study of engagement and drop out from primary care

    Brief description of the study purpose This study aims to understand how Australian men use general practice (GP) healthcare over time, including how often they return for follow up visits and how many stop attending care after an initial visit. Who is it for? Males or females aged 16 years or older who has at least one recorded GP consultation between 2015 and 2025, with at least 12 months since their last visit, at an Australian general practices participating in the MedicineInsight program and who consented to share their medical information Study details This research uses existing, deidentified electronic health record data from MedicineInsight, a national database that collects information from consenting general practices across Australia. There is no direct involvement required from participants, as no new appointments or treatments are provided as part of this study. All information analysed has already been recorded during routine GP visits. By examining patterns of GP attendance, reasons for visits, and follow up care over time, this study aims to identify factors that help keep men engaged in healthcare. It is hoped findings from this study will support the development of better strategies to keeping men engaged in care until their health needs are met, in order to reduce preventable illness, and improve long term health outcomes for Australian men.

  • Effectiveness of the ‘Buzzy’ High-Frequency Vibration Device on Cannula-Related Anxiety for Young Adults Undergoing Anaesthetic: A Randomised Control Trial

  • Buprenorphine vs tapentadol for pain management post haemorrhoidectomy: an open-label randomised clinical trial (BOLT)

    Studies have shown that 20-40% of patients experience severe pain following haemorrhoidectomy surgery, often requiring opioid analgesics. Although various pain management strategies have been explored, no universally accepted approach has emerged. Emerging opioids have shown great promise for postoperative pain after haemorrhoidectomy surgery. Tapentadol and buprenorphine are both atypical opioids with multimodal action and reduce gastrointestinal side effects due to their opioid sparing effects, that may be beneficial for patients after haemorrhoidectomy surgery. However, these two opioids have not been directly compared, emphasising the need for research to inform safe prescribing. This RCT directly aims to directly compare the efficacy of buprenorphine and tapentadol (primary: AUC bowel motion pain) and safety (AEs, constipation), informing safer prescribing to accelerate recovery, reduce opioid loads, and mitigate population-level harms in opioid-vulnerable surgical cohorts.

  • Can a computer program help identify stroke patients faster in the Emergency Department? A study of automated triage note analysis.

    SCANSTROKE study will assess the utility of a software tool to identify ED patients suitable for acute stroke treatment. The tool will assess language present in the documented notes by ED triage clinicians. This will be compared against whether patients were actually activated as a stroke code at the time and whether they ended up having a stroke as their final diagnosis.

  • GIM-407 Phase 2a Pilot Study in Adults with Coeliac Disease

    The purpose of this research study is to investigate how safe GIM-407 is when it is administered to adult participants with Coeliac Disease and how this investigational treatment is absorbed and processed by the human body. This study will also look to see if any indicators of the disease are affected by GIM-407. Participants will receive either GIM-407 or a placebo, and be asked to drink a slurry containing a measured amount of gluten each day for several weeks (this is called a 'gluten challenge'), under close medical supervision. The gluten challenge is done to monitor how their body responds to gluten while they are receiving the study treatment.

  • A clinical safety trial evaluating an amended shortened version of the apomorphine pen initiation recommendations in people with Parkinson's disease.

    This pilot safety clinical trial proposes an amended shortened version of the apomorphine pen initiation for patients with no prior history of PD medication induced nausea. This streamlined approach has the potential to significantly improve the initiation process for PD patients, making it quicker without compromising safety. The initial dose will be in line with current recommendations of 2mg (0.2mL) without the presence of an antinausea medication. The dose will be slowly titrated as required until the optimum dosage has been reached. This study will provide valuable insights and pave the way for protocol adjustments that benefit both patients and healthcare providers.

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