ANZCTR search results

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

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31193 results sorted by trial registration date.
  • A cluster randomised controlled trial of a consumer behaviour intervention to reduce the average energy, saturated fat, sugar and sodium content of the online canteen lunch orders of primary school students: The 'Click & Crunch' Trial.

    The aim of this study is to assess the effectiveness of integrating consumer behaviour strategies such as menu labelling, positioning, feedback, incentives, prompts, and price into an online canteen ordering system in reducing the average energy, saturated fat, sugar and sodium content of student lunch orders. The study will employ a clustered randomised controlled design. NSW primary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed through a nutritional analysis of lunch order purchases recorded by the online ordering system at baseline and 12 months follow-up.

  • A Rapid Diagnosis Discussion (RaDD) tool for reducing misdiagnoses of patients presenting to emergency rooms with abdominal pain

    Errors in diagnosis, including delays and receiving an incorrect diagnosis, have serious consequences for patient safety and patient outcomes. Whilst system factors play a role in diagnostic errors, cognitive biases have been identified as being a significant contributor to diagnostic error. Evidence suggests that to address cognitive bias in diagnostic decision-making, getting a second opinion and asking questions designed to challenge bias may be effective at reducing diagnostic error. The purpose of this project is to address cognitive bias in diagnostic decision-making in Emergency Departments (ED). To do this, an intervention will be trialled which involves performing a second independent review of all abdominal pain cases presenting to Box Hill Hospital Emergency Department, followed by a structured discussion to prompt questions, broaden thinking and challenge assumptions. Following the first clinician’s assessment, an independent review will be conducted by a second clinician in the ED followed by a structured discussion between the first clinician and the second opinion. The second part of this intervention, the structured discussion, will be guided by a standard set of questions. Existing ED practices typically involve repeated ad hoc clinical examination by multiple clinicians, so it is anticipated that patients presenting to the ED with abdominal pain will not notice a change in their care, or find this process burdensome. References Blumenthal-Barby, J., & Krieger, H. (2014). Cognitive biases and heuristics in medical decision making: A critical review using a systematic search strategy. Medical Decision Making, 35(4), 539-557. Croskerry. (2003). The importance of cognitive errors in diagnosis and strategies to minimize them. Academic medicine, 78(8), 775-780. Graber, M. L., Franklin, N., & Gordon, R. (2005). Diagnostic error in internal medicine. Arch Intern Med, 165(13), 1493-1499.

  • Impact of a tailored exercise program on prostate cancer patients treated with androgen deprivation therapy: A pilot interventional study in the Australian regional setting

    This study is assessing the impact of an exercise program on quality of life and physical function in prostate cancer patients being treated with hormone therapy. Who is it for? You may be eligible for this study if you have biopsy proven prostate cancer and are currently on hormone therapy i.e. androgen deprivation therapy. Study details All participants will undertake an exercise program consisting of 3 one-on-one sessions with an exercise physiologist, followed by 14 weeks of group training and home-based exercises. Participants will answer a number of questionnaires, perform a number of physical function tests, and have their body composition assessed using a body composition scan. It is hoped this study will demonstrate the effectiveness of exercise in improving patient quality of life and daily function, particularly in patients from rural/regional settings.

  • A Phase II, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of topical lidocaine spray in patients with Postherpetic Neuralgia

    The primary purpose of this study is to evaluate the clinical efficacy and safety of topical lidocaine spray in reducing neuropathic pain in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo spray.

  • Maintain Your Brain (MYB): a 3-year study of a personalised online program to prevent cognitive decline and incident dementia amongst community dwelling 55-77 year olds.

    MYB is a randomised controlled trial of multiple online interventions designed to target modifiable risk factors for Alzheimer’s disease and dementia. Risk factors to be addressed are physical inactivity, cognitive inactivity, depression/anxiety, overweight and obesity, and poor diet. Up to four intervention modules (physical activity, nutrition, brain training and peace of mind) will be administered based on individual risk profiles. Each module will be initially delivered using MYB eHealth platform over 10 weeks. In this part of the intervention, participants complete their assigned modules back-to-back, noting that the total number of modules is variable depending on individual’s risk factors. In practice this will translate to a minimum of two modules and a maximum of four modules, over a maximum of 12 months. Booster sessions (specific to each module) and ongoing monitoring will then continue for three years. Follow-up assessments measuring these risk factors and cognition will be completed annually for three years. The control group (“information” group) will receive basic psychoeducation online about dementia risk factors via a website with set activities organised by corresponding module eligibility (i.e., information activities themed around peace of mind, brain training, nutrition and/or physical activity). They will otherwise undertake the same enrolment, baseline and annual follow-up assessments.

  • How to "choosebetweenamab" for severe asthma, comparing treatment with mepolizumab and omalizumab for patients with severe allergic and eosinophilic asthma.

    Hypothesis: We propose in patients with the dual phenotypes of severe allergic and eosinophilic asthma, that Mepolizumab is as effective as Omalizumab. However, we will also go on and identify key clinical biomarkers that will clarify which patients will respond best to each of these interventions. This study will be the first direct clinical comparison of these agents and will apply expert clinical characterization, along with cutting edge biotechnology to better inform treatment choices for severe asthma. This is an important and urgent management problem facing the Australian pharmaceutical scheme, where imprecision in prescribing will result in reduced clinical effectiveness as well as substantial and sustained costs.

  • Participants with advanced solid tumor will be treated with KN046 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of KN046.

    This is an open-label, multi-center, dose-escalation phase I study. The primary purpose of this trial is to evaluate the safety and tolerability as well as the preliminary efficacy of KN046 in participants with advanced solid tumors. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced malignant solid tumor with no standard therapy is available. Study details All participants enrolled in this trial will receive KN046 intravenously every two weeks for 6 months or until excessive toxicity, disease progression, patient consent withdral, physician's judgment (whichever occurs first), up to 2 years. The dose received by each participant depends on the time of their enrolment. KN046 is a biological drug for treatment of advanced solid tumor. As a part of the clinical research study patients will have regular blood tests, physical examinations, Tumor imaging examinations by either CT or MRI. It is hoped this study will contribute important safety and efficacy information as well as to determined the optimal dose of KN046 to administer for treatment.

  • Optimising balloon expulsion testing and sensory testing in patients with faecal incontinence and chronic constipation

    Chronic constipation and faecal incontinence carry significant health and economic burdens on individuals as well as the health system. Initial treatment remains conservative including medications and dietary modifications. However should these be ineffective, guidelines recommend investigating for physiological abnormalities by anorectal physiology testing including ARM and BET. The results of these are subsequently used to guide prescription of second line management including biofeedback therapy, neuromodulation and surgical interventions which when used appropriately demonstrated positive outcomes. Given the central role of anorectal physiological testing, there remains a lack of standardisation when conducting these procedures and subsequently, we remain uncertain whether the results produced are comparable. This applies to the study protocol itself, the equipment used during testing and analysis of results. Literature has even suggested that in cases of faecal incontinence, it may be beneficial for individual units to have their own range of values for defining abnormalities. The sensory component of defaecation, namely alterations in visceral perception and rectal compliance has also become increasing studied and tested. Determining type and degree of dysfunction in these have implications on provision of treatment. Barostat methodology is now widely used to assess sensory components of defaecation but different protocols exist, mainly with varying duration and equipment for the procedure. As a result, normal cut-offs remain unclear.

  • A comparison of manual therapy interventions of the upper back in addressing shoulder impingement syndrome in people over 40 years old.

    The aim of this RCT is to assess whether interventions addressing the thoracic spine are effective in reducing shoulder impingement pain. Participants with shoulder impingement pain will be randomised to receive one of: sham treatment, manual therapy to the thoracic spine, or manual therapy to the thoracic spine and shoulder treatments. All treatments will be delivered by a registered osteopath using pragmatic standard osteopathic manual therapy techniques. Outcome measures will be shoulder pain and disability questionnaires, visual analogue scales ,global rating of change diagram, patient-specific function scale diagram, and thoracic posture measure and thoracic range of motion measured with an inclinometer.

  • ImpleMENTing meditatiOn into heart disease clinical settings (The MENTOR Study)

    This project aims to improve care for adults with heart disease by building the evidence for meditation as an adjunct non-pharmacological self-management strategy to improve health-related outcomes for adults after an acute cardiac event. This meditation intervention aims to provide an avenue for optimising self-management of depression and anxiety symptoms, known to be high after an acute cardiac event or hospitalisation, which may enhance the capacity for adults to adhere to conventional exercise-based CR, self-manage their symptoms and reduce re-hospitalisation rates. The proposed study design is an open-label parallel group pilot RCT with post-intervention follow up. The researchers hypothesise that a meditation intervention will improve self-reported depression and anxiety at 6 weeks, which will be sustained at 3-month follow-up. Post-intervention follow-up will be undertaken to better understand consumer perspectives of meditation as an adjunct strategy for the alleviation of depression and anxiety symptoms. Findings from this study will inform a phase III randomised controlled trial (RCT) that will be used to inform future policy and guideline development.

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