ANZCTR search results

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

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31061 results sorted by trial registration date.
  • N Acetylcysteine in Bronchiectasis.

    This pilot study aims to examine the anti-inflammatory and clinical effects of oral N acetylcysteine( 2400 mg/day) in bronchiectasis over a 6 week period compared with placebo.We hypothesise it will improve these outcomes.

  • Securing jugular central venous catheters with dressings fixed to a liquid adhesive (Mastisol) in an Intensive Care Unit population: a randomised controlled trial re-thinking evidence-based care delivery

    Central venous catheters (CVCs) placed in the internal jugular vein have been associated with increased risk of central line-associated infection and CVC failure compared to subclavian CVCs. Effective dressing and securement of internal jugular CVCs can reduce the risk of such complications, but dressing and securement is often inadequate due to 'drag' of infusion lines on the CVC and intermittent 'catching' of the CVC lines on other objects. Dressing failure also increases the risk of medical adhesive-related skin injury and central line-associated bloodstream infection due to repeated dressing changes. Mastisol Liquid Adhesive (MLA) is a non-water-soluble gum mastic liquid adhesive designed to improve dressing adherence and integrity. MLA has been shown to not increase bacterial growth and improve dressing adhesion in small studies, but has not been rigorously tested in a randomised controlled trial. The aim of this study is to investigate the effectiveness of MLA in reducing dressing changes, adverse events (e.g. device failure, infection and MARSI), clinician workload and costs associated with IJ CVCs. It is hypothesised that dressings secured with MLA will required changes less frequently, and therefore be associated with less adverse events, lower clinician workload and costs.

  • WHOS Coming Off Buprenorphine: understanding the experience of withdrawing from buprenorphine medication in the treatment of opioid dependence

    The introduction of long acting depot (modified release) buprenorphine subcutaneous injections in recent years is a significant addition to the medication options for the treatment of opioid dependence. These medications are long acting and enable 'once a month' doses rather than daily medication such as sublingual buprenorphine - which are often associated with inconvenience and cost for patients and health services. However little is known about the nature of the withdrawal syndrome that occurs if patients discontinue depot buprenorphine medication. The aim of this study is to describe the profile of withdrawal signs and symptoms in participants discontinuing opioid treatment with a 4-weekly depot buprenorphine formulation, and to compare against the withdrawal profile of a parallel group of participants discontinuing opioid treatment using sublingual buprenorphine. Participants will be monitored over a 16-week admission in a residential rehabilitation unit that assists clients withdrawing from opioid agonist treatment; and participants will withdraw using the buprenorphine formulation they are prescribed prior to the admission (a non-randomised comparison group). The main outcome is opiate withdrawal severity (subjective and objective features) over the course of the admission, with secondary outcomes of cravings, adverse events, general heath, sleep measures and patient experience. .

  • A Randomised Controlled Trial of the Effectiveness of a Media-based Intervention on Intentions to Seek Help for Mental Health Difficulties among Australian Men

    This online randomised controlled trial aims to test the effectiveness of a 4-minute purpose-made intervention video on increasing Australian men's intentions to seek help from others when they are experiencing mental health difficulties, compared with a control video. We hypothesise that there will be a significant change in scores on the General Help-Seeking Questionnaire - Self from baseline (T1) to post-intervention (T2 - after viewing the video) in the group that views the intervention video (intervention group), but not in the group that views the control video (control group). The video takes a well-known song and adapts the lyrics with the intention to encourage men to seek support from others when they are experiencing mental health difficulties. The lyrics focus on how men are typically encouraged to remain stoic, to keep their difficulties to themselves, and to never cry, but encourages them to express their feelings and seek support when they are not coping well. The video focuses on a group of diverse men who meet in a large community hall; it has the appearance of a support group. The video begins with a single man beginning to sing the lyrics to the adapted song; he is gradually joined by others until all men have stood and are taking part in this spontaneous 'choir'. The video ends with the call to action printed on the screen 'When the going gets tough. Get Talking' and a link to the study website, which will house information for gaining various types of mental health support. If the video has no negative effects on participants, it will subsequently be released into the public domain and promoted using a largely social media campaign.

  • The effect of a short-term potato-enriched diet on muscle protein synthesis in recreationally active men

    The World Health Organization (WHO) recommends performing both strength/power (resistance-based exercise) and endurance activities (walking, running, cycling, swimming) for wellbeing. Appropriate nutritional support is essential to maximize the beneficial effects of any training program. In this regard, it is well accepted that the ingestion of high quality animal protein (meat and dairy products) as well as specially formulated high-protein bars and drinks have an additive effect in optimizing training-induced increases in muscle growth and strength following resistance-based exercise. In contrast, endurance-based training adaptations are amplified by the ingestion of carbohydrate-rich foods/supplements that rapidly restore muscle and liver glycogen stores and support skeletal muscle remodelling (i.e., mitochondrial biogenesis). Despite their benefits, current trends in consumer preferences driven by environmental factors, health benefits and/ or ethical reasons have brought to the forefront a need to advance knowledge of alternate food and beverage sources beyond conventional products. Vegan dietary practices are characterized by the avoidance of animal-based food ingredients, including dairy products and eggs. Such diets have been associated with a reduced risk of cardiovascular disease and type 2 diabetes. The proportion of individuals choosing to follow a vegan diet has increased in many industrialized nations and trend analysis predicts that their influence on the food sector will continue to grow. While numerous studies have investigated the postprandial muscle protein synthesis response to the ingestion of animal-based (dairy and meat) protein sources, little is known about the muscle protein synthesis response to plant-based proteins. To date, the anabolic properties of such plant-based proteins have only been investigated in limited protein sources. The primary aim of this project is to determine the effect of a non-animal protein diet on rates of muscle protein synthesis consumed during a short-term combined (‘concurrent’) resistance and endurance training program in healthy young males. It is hypothesized that a short-term, non-animal diet in combination with concurrent exercise will increase the synthesis and abundance of individual muscle proteins involved in the responses to both strength- and endurance-based exercise.

  • A pilot trial of a mental health app for Emergency Service Workers: the Build Back Better app

    Our research team has been funded by the Australian Government Department of Home Affairs to provide a suite of integrated mental health resources for individuals affected by the 2019/2020 bushfires (emergency service workers and their families), including an app-based prevention intervention tailored to the needs of this population. This pilot study aims to examine the feasibility of a smartphone application: Build Back Better; in providing evidence-based prevention strategies for anxiety, depression and PTSD for Emergency Service Workers and their adult family. The preliminary effectiveness for whether the intervention leads to any improvement in outcomes such as distress, wellbeing and common mental disorders will furthermore be explored. Participants will complete assessments at baseline and 1 month post- baseline. The smartphone application is intended to be used in a larger scale study aimed at promoting mental health and wellbeing within Emergency Service Workers and their families. The research questions/hypothesis that this study seeks to address are: 1. Explore the engagement with the components the app? 2. Explore the level of satisfaction with the app? 3. Explore the preferences of these individuals in terms of app content, format and design? 4. Explore the preliminary effectiveness in terms of improvements in wellbeing and symptom reduction? These include changes in alcohol and other drug use; self-reported recovery; health-related quality of life and mental health symptoms.

  • Peer Support as an Adjunct Treatment for Eating Disorder Patients Waitlisted for Clinical Treatment

    This study seeks to examine the feasibility and effectiveness of using peer support workers with lived experience of an eating disorder (ED) in the provision of treatment for EDs. While peer support and mentorship programs have been used in general mental health, there is little research to support their use in the field of EDs. However, there is some evidence to suggest that peer-led interventions might help overcome implementation barriers to clinician-led interventions and may increase feelings of hope and empowerment and decrease ED risk factors. For individuals waitlisted for treatment with the Statewide Eating Disorder Service, we hypothesize that peer support workers with lived experience of an ED offering 8 sessions of online guided self-help using the book “Eight Keys to Recovery from an Eating Disorder” will produce larger effect size decreases in eating disorder symptoms than guided self-help using a trainee health worker or wait-list alone.

  • The SerOzNET study seeks to better understand the safety and efficacy of the COVID-19 vaccines in people with cancer.

    This study will investigate the serological and immune response of cancer patients to the COVID-19 vaccine Who is it for? You may be eligible to join this study if you are aged 5 and above, have not received COVID-19 vaccination, with one or more of the following criteria: • Currently on chemotherapy • Currently on immunotherapy • Currently on hormonal therapy • Received chemotherapy 6-12 months ago • Have an allergy to either a vaccine or an anticancer treatment • Have a diagnosis of multiple myeloma, CLL, or low grade lymphoma, are eligible for government COVID-19 vaccination program and willing to receive the vaccine Study details All participants in this study will have serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting) at baseline, day 7 post initial vaccination, at booster appointment, 7 days post booster and at 3 months after booster vaccination. Administration of the vaccine itself and real-time collection/assessment/management of toxicities will not form part of the SerOzNET study. Patients will receive vaccination at their usual GP clinic or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice. It is hoped this research will contribute to the cancer immunology field in order to assist oncologist improve health outcomes for patients with cancer. The study involves serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting).

  • Early Peanut Immunotherapy in Children (EPIC) - a trial of peanut oral immunotherapy to induce desensitisation in preschool aged children with a peanut allergy.

    The EPIC study is a randomised controlled trial (RCT) to establish the efficacy, safety and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol in children under 5 years of age in WA. We hypothesise that low dose peanut OIT in young preschool aged children will be effective and tolerable. Participants with peanut allergy will be randomised 1:1 to receive either peanut OIT or standard care (peanut avoidance) for 12 months. The OIT program consists of a daily dose of peanut flour incrementally increased under medical supervision every 2 weeks until a maintenance peanut protein dose of equivalent to approximately 1.5 peanuts is reached. After 12 months, all participants will have an oral food challenge (OFC) to establish their peanut eliciting dose, which will be defined as the amount of peanut they can consume before having an allergic reaction. We will compare the eliciting dose between participants receiving OIT and controls to determine the efficacy of peanut OIT. We will also collect and report quality of life and adverse event data to assess efficacy, safety and tolerability of this treatment. With this project, we are responding to an area of unmet need and consumer demand to provide access to food allergy treatments in Australia that are currently available overseas, using a translatable approach that could be applied to other foods and underpin a future national approach to food OIT.

  • Integrating the Choosing Wisely five questions into family meetings in the Intensive Care Unit: a randomised controlled trial.

    This study was approved as a quality improvement project by the Quality Improvement Head of Department at the North Metropolitan Area Health Service (GEKO #32792). This committee provided ethical approval for the investigators to consent and enrol participants into this interventional study. Summary of research project: Families presenting to the Intensive Care Unit (ICU) will be randomly allocated to either the control or intervention group. The intervention group will receive the Choosing Wisely five questions as pre-reading. The control group will not participate in any pre-reading. The family will then undergo a family meeting with the ICU doctor and nurse as planned. Post-family meeting the family member/s, doctor and nurse will complete a survey. The goal of this study is to investigate whether the pre-reading improves families' perceived involvement in decision making on behalf of their family member who is a patient in the ICU.

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