ANZCTR search results

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

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30855 results sorted by trial registration date.
  • An online skills-based educational tool for eating disorders: SkillED Program Evaluation

    The current study aims to evaluate a recently developed online, skills-based educational tool, SkillED. The proposed program has been specifically developed to provide psychoeducation and motivation for individuals with a clinical or subclinical diagnoses of an eating disorder. Overall, we aim to investigate: (1) Program Effectiveness and Safety: The changes in participants’ eating disorder symptomology, general mental health, quality of life, self-perceived skill-level, understanding, knowledge and confidence in eating disorders and the motivation to seek help/treatment, in addition to self-harm and suicidal risk assessment and self-reported weight changes. (2) Program Evaluation: The extent to which participants find the program content and delivery format acceptable and useful, with identification of areas of improvement and consideration to the broader feasibility of online skill-based programs for individuals with an ED across the diagnostic spectrum. We anticipate that engagement with SkillED will result in improvements in eating disorder symptoms, overall wellbeing, knowledge and confidence in understanding of eating disorders, and increase motivation to seek treatment and actual help-seeking behaviours.

  • Evaluating the acceptability, feasibility, and short-term effects of a coach-supported, online parenting program (‘PiP-SP+’) to empower parents whose adolescents have suicidal thoughts and/or behaviours.

    This study aims to evaluate the acceptability, feasibility, and short-term effects of a coach-supported, individually-tailored online parenting program for parents of adolescents with suicidal thoughts and/or behaviours in the context of anxiety or depression. The program aims to increase parental self-efficacy to support their teenage child by providing personalised feedback about their current parenting and equipping them with evidence-based parenting strategies to respond to adolescent suicidal thoughts/behaviours, and anxiety and depression. The online intervention consists of up to 13 parent self-guided modules covering different topics related to parenting an adolescent who has suicide risk in the context of anxiety or depression. Online modules are supplemented by up to 9 one-on-one videoconferencing sessions with a trained coach to support parents in making changes in their parenting. We aim to evaluate short-term effects of the program in improving 1) parental self-efficacy to respond to adolescent suicidal thoughts/behaviours, 2) parental self-efficacy in responding to adolescent non-suicidal self-injury 3) parenting behaviours to reduce adolescent anxiety and/or depression, 4) carer burden, 5) family functioning, 6) quality of mental health support, 7) adolescent symptoms of anxiety 8) adolescent symptoms of depression,, and 9) adolescent’s perception of parental support if they were suicidal or self-injurying. It is hypothesised that: (1) Parents will find PiP-SP+ acceptable and feasible to implement; (2) From pre- to post-intervention (4 months later), parents will report improvements in parenting self-efficacy, parenting competencies, family functioning, quality of mental health support, carer burden regarding management of their adolescent’s suicide risk and mental health problems. Additionally, parents will report reduced anxiety and depressive symptoms in their adolescent. (3) From pre- to post-intervention (4 months later), adolescents will report reductions in anxiety and depressive symptoms. Additionally, adolescents will report improvements in the perception of parental emotional support if they were suicidal or self-injuring.

  • Foot muscle measures of strength and cross-sectional area by ultrasound in the diabetic population.

    Diabetic Peripheral Neuropathy (DPN) is a prevalent and debilitating condition. One way of detecting and managing DPN is to assess the Intrinsic Foot Muscles (IFM). Ultrasound (US) has been used to detect IFM muscular atrophy in DPN patients. In addition, exercise is beneficial in delaying the usual course of DPN, skin damage and ulceration. However, diabetic patients have lower physical activity rates due to limitations such as difficult access to therapy, poor compliance, and limited support to maintain exercise therapy. Therefore, this study aims to assess whether a newly developed biofeedback device, 'Archercise' – a foot muscle exercise and strengthening tool, can correlate IFM Cross-Sectional Area (CSA) measured by US with foot arch control and performance. From this, IFM muscular and functional changes can potentially be detected earlier. In addition, IFM strength and control can be monitored and improved.

  • A pilot study of the JiffyStent ureteric stent inserter for patients with acute renal colic requiring a ureteric stent.

    Pain from a kidney stone is excruciating. Many people who present to an emergency department with kidney stone pain require admission to hospital and a trip to the operating room to insert a stent to help relieve the pain. The JiffyStent is an innovative medical device that allows the insertion of a ureteric stent in the emergency department without the prolonged wait and need to go to the operating room. This is a proof of concept pilot study to show that the JiffyStent device is able to quickly and correctly insert a stent into the ureters of patients while they are still in the emergency department. A successful outcome will lead to a pivotal multicentre clinical trial necessary for regulatory approval thereby making the JiffyStent device available for widespread use.

  • Experimenting with uncertainty: A strategy to help with excessive worry and anxiety

    The primary aim of this study is to investigate the benefits of two sessions of behavioural experiments targeting negative beliefs about uncertainty compared to a waitlist control for generalized anxiety disorder. The secondary aim is to investigate the proposed mechanisms of action (i.e., intolerance of uncertainty, metacognitive beliefs, threat appraisals) that underpin generalized anxiety disorder. Participants in the treatment group will begin the intervention immediately, and their results will be compared with a waitlist control condition who will receive the same intervention after a one-week wait period.. Outcome measures will be administered at baseline, post treatment and 1-week follow-up. Based on existing studies of behavioural experiments for generalized anxiety disorder it is hypothesised that: 1) behavioural experiment condition will be more effective in reducing symptoms of excessive worry and anxiety than waitlist control at post-treatment and follow up; and 2) behavioural experiments will yield greater improvements in intolerance of uncertainty, metacognitive beliefs, and threat appraisals, compared to waitlist control.

  • A Phase I, Open-Label Study to Evaluate the Safety and Pharmacokinetics of APC201 in Healthy Volunteers

    The purpose of phase 1 study is to evaluate the Pharmacokinetics, Safety, Tolerability of APC201 in Healthy Adults.

  • Effect of Nutritional INterventions on Autophagy (The NINA Study)

    Autophagy is a critical process that helps keep the body’s cells clean and healthy. It is thought to be sensitive to nutrition. Using a test performed on blood that we have developed to measure autophagic activity in humans, This project aims to determine whether a 4-week modification of dietary macronutrient profile (within the context of a balanced diet) in healthy adults will change autophagic activity.

  • An observational study exploring outcomes following concussion to optimise recovery

    This observational study will investigate injury characteristics and clinical assessments to measure post-concussion symptoms at different time points in the first year post injury and use this information to predict people who are more likely to have a poor outcome after concussion. Participants will be recruited via hospital emergency departments following initial medical practitioner assessment and concussion diagnosis. Once consented into the study, participants will complete a questionnaire about their concussion injury and medical history, in addition to having a blood and saliva sample taken. Other clinical assessments and an MRI scan will also be completed within 4 days of their injury. At 2 weeks, 1-, 3-, 6- and 12- months following injury, participants will be contacted via telephone to complete a follow up questionnaire about their concussion symptoms and quality of life post injury. Having a better understanding of people who are at risk of developing persistent symptoms following a concussion will enable more targeted and timely clinical care to minimise distress and disability that may be experienced as a result of injury.

  • Evaluation of MV140 in older adults

    The Australian population has a large proportion of older adults, and it is known that people of age greater than 65-years-old have a six-fold increased risk of acquiring recurrent urinary tract infections. Recurrent urinary tract infections cause significant burden to quality of life and result in a large number of presentations to general practitioners and hospitals for treatment. They are a significant cost to patients and the healthcare system. Whilst prophylactic use of antibiotics has been shown to be effective in the prevention of recurrent urinary tract infections, due to growing concern regarding antibiotic resistance, alternative treatments are being sought. MV140 is a form of bacterial vaccine, which means it uses de-activated strains of bacteria to improve your immune system’s response to infection. MV140 includes strains from 4 of the most common types of urinary tract infection bacteria (enteroccocus faecalis, escherichia coli, klebsiella pneumoniae, and proteus vulgaris). MV140 is not designed to treat such infections once patients have them, but is designed to help your immune system prevent them from developing in the first instance. Our goal is to determine whether MV140 is effective at preventing recurrent urinary tract infections in people aged greater than 65-years of age.

  • Effect of adjunctive treatment using Bruder Moist Heat Eye Compresses + Optimel Manuka+ Dry Eye Drops on dry eye

    Dry eye disease is a chronic, multifactorial disorder characterised by instability or poor quality of the tear film. It is associated with a wide variety of signs and symptoms, such as discomfort or visual disturbances (Lemp & Noulks, 2007). Due to the constancy and potential severity of these symptoms, dry eye patients may have their quality of life severely impacted, particularly with activities requiring visual attention like reading, driving or computer work (Uchino et al., 2014). Prevalence of dry eye disease can range from 5–50% depending on the population, with prevalence increasing with age or chronic illnesses (Rouen & White, 2018). Management is targeted towards symptomatic relief and tear film homeostasis, whether by improving tear production or reducing tear evaporation. Previous studies have shown that the Bruder Moist Heat Eye Compress and Optimel Manuka+ Dry Eye Drops have been effective in managing dry eye disease. The former seeks to improve meibum secretions to stabilise the tear film (Tan et al, 2018), whereas the latter has both anti-inflammatory and antibacterial properties to alleviate symptoms of dry eye disease (Tan et al., 2020). However, conventional or standalone treatments may not be effective for everyone; as such, a combination of the Bruder mask and manuka honey eye drops may offer a novel approach to treating dry eye disease. The proposed research aims to assess the effectiveness of this combination and provide evidence for its potential use in clinical practice. It will use both subjective and objective metrics to evaluate changes in tear film properties, eyelid health and comfort, thereby providing valuable information on the potential benefits of adjunctive therapy in comparison to conventional treatments for dry eye. Overall, this study will make an important contribution to the field of dry eye disease treatment by providing information on a novel approach to treating this condition. The results of the study will provide valuable information to both healthcare professionals and patients, and may lead to the development of new and improved treatment options for dry eye disease.

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