ANZCTR search results

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

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31122 results sorted by trial registration date.
  • A comparison of 2 different medicated ointments with placebo for pain relief after banding of haemorrhoids.

    Haemorrhoidal symptoms are among the commonest complaints of mankind, it can occur in up to 80% of the population, involving any age and affecting both males and females equally. Surgical haemorrhoidectomy is most commonly used for 3rd or 4th degree haemorrhoids. However, surgery is associated with severe postoperative pain that is a source of such anxiety that some patients decide not to undergo the operation. Due to this, another non-surgical method can be used such as rubber band ligation, however this still requires pain relief. Research has suggested that current forms of pain relief are short term, caused more pain. Therefore, topical local anaesthetic agents are the next appealing option although have not been as successful as anticipated. Lignocaine in combination with Diltiazem are options that have not been used in this area and could potentially be more effective in relieving pain. This trial will examine the role of diltiazem and lignocaine in reducing post-procedure pain.

  • Investigation into the psychosocial and behavioural impact of genetic testing for familial melanoma

    Brief description of the study purpose The study aims to Investigate the psychosocial and behavioural impact of genetic testing for familial melanoma. It also evaluates a training program for clinicians to provide genetic testing for familial melanoma, based on participant satisfaction. Who is it for? You may be eligible for this study if you are 18 years or older, with 3 primary melanomas and/or a family member with 1 or more invasive melanomas and 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family. Study details Participation in the study will involve a pre-testing genetic counselling and education visit. You will be seen by either a genetic counsellor (standard practice of care), or by a clinician who has received training to provide genetic testing (the 'intervention group'). Participants will then have their saliva collected for genetic testing, and will attend a second visit to receive their test results. At both visits, participants will be asked to complete questionnaires (approx 30 mins). One month after receiving their genetic test results, participants will asked to complete a phone interview where questions about their experience in the study will be discussed. Participants will also be required to answer questionnaires about the psychological impact of genetic testing and regarding their sun protective behaviour after results have been received. A link to the questionnaires will be emailed to participants at 1 week, 3 months and 12 months after receiving their results, and can be completed online. It is hoped this study will provide greater insight into the role of genetic testing and the impact on mental health, and sun protective behaviour.

  • Rapid Administration of Methoxyflurane to patients in Emergency Department (ED) Study (RAMPED)

    The Alfred Hospital is an adult major trauma centre, and receives in excess of 65,000 patient presentations per year. This study is an open-label randomised controlled trial of one dose of Methoxyflurane (3mL) administered after streaming to eligible patients compared to standard care. The primary outcome will be defined as the proportion of participants achieving significant pain reduction. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED. Secondary outcomes will be the mean pain score at 30 min, the proportion of participants achieving a drop in pain scores of at least 3 standard points on the numerical 11-point pain scale, and the use of any opioid analgesia. Participants will be asked to indicate the intensity of pain at 30, 60, and 90 min after administration of analgesia, with a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score.

  • Early Matched Care For Australia Post Employees (EMCAP) with work-related injuries and at risk of delayed return to work.

    Workplace injuries have a major impact upon workers, employers and society in general. While most work-related injuries heal within a few weeks, a considerable proportion of workers have ongoing pain and disability for months and years following the injury (e.g., Henschke et al., 2007, Social Research Centre, 2018). A common corollary following a workplace injury is chronic pain. In 2007 the estimated total cost of chronic pain in Australia due to absenteeism and lost productivity while at work was $11.7 billion (Access Economics Report, 2007, and their latest report, 2019, indicates these figures have multiplied in the intervening period). Chronic pain is often associated with markedly reduced quality of life, high levels of distress and often co-occurs with mental disorders, such as depression and anxiety (e.g., Arnow et al., 2006). Furthermore, there is only a brief window of opportunity to prevent these sorts of outcomes for injured workers. The longer injured workers are away from work, the greater their risk of never returning (e.g., Landstad et al., 2009). In Australia chronic back pain has been identified as one of the major reasons middle-aged workers drop out of the workforce (Schofield et al., 2011).

  • A pilot study to trial Normothermic EX vivo perfusion prior to Transplantation of the Kidney

    This is a feasibility study of normothermic machine perfusion technology in human DCD kidneys deemed suitable for transplantation. If preliminary results are encouraging a larger prospective RCT will be required to confirm whether this technology improves Kidney transplant outcomes in the clinical setting. Experimental data and early non randomised clinical studies from Europe appear to show a significant benefit, by reducing the need for post transplant dialysis.

  • The efficacy of radial shockwave therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial

    Achilles tendinopathy is a common, painful and disabling musculoskeletal condition. There is a treatment called radial shockwave therapy (rSWT) that produces a pressure wave that enters the Achilles tendon. Some studies report positive findings for this treatment in insertional Achilles tendinopathy but it is not certain whether rSWT is better than placebo. The proposed study is a two-arm, parallel group, double-blind randomised prospective trial. Participants will be block-randomised into sham rSWT or rSWT groups with a 1:1 ratio. All participants will receive weekly rSWT (sham rSWT or rSWT) once per week over a three-week period, and will also receive an identical evidence-based exercise intervention to be completed for the duration of the trial, which removes ethical concerns of withholding treatment. Participants and outcome assessors will be blinded to treatment allocation.

  • Clinician and patient perspectives of hospital falls prevention education

    Falls are a debilitating and common problem in Australian hospitals and it is estimated that between 310 falls occur per 1,000 bed days in Australian hospitals. Even though they are associated with increased length of stay and injuries, falls mitigation strategies have not had a great deal of success to date in hospital environments. Previous attempts to prevent falls have focused on clinician education and environmental modifications. The current project will use qualitative methods for a series of interviews with patients and clinicians to understand their views and knowledge on falls prevention educational interventions.

  • A randomized controlled study of gut health and Fibre-fix in people with IBS who are on a low FODMAP diet

    This study will examine the effect of Fibre-fix (dietary fibre supplement) on the human gut microbiome and faecal metabolites of people with Irritable Bowel Syndrome (IBS) who consume a diet low in fermentable oligosaccharide, disaccharides, monosaccharides and polyols (FODMAP). A low FODMAP diet reduces the intake of fermentable fibres, leading to insufficient fermentation by the gut microbiota. This can thereby reduce the production of short chain fatty acids (SCFA, e.g. butyrate) in the large intestine and influence on modulation of sleep and mental health. A randomized double-blind placebo controlled study design is proposed to examine whether Fibre-fix supplement, added to an existing low FODMAP diet may help modulate gastrointestinal function, improve markers of sleep and mental health and promote increased quality of life in IBS patients. Participants will provide stool samples, and complete questionnaires about sleep and mental health before and after the 3-week intervention. Gut health biomarkers: faecal microbiome composition, faecal pH and butyrate levels, and alteration of sleep and mental conditions will be examined. A repeated measures ANOVA using the Statistical Package for the Social Sciences (SPSS) version 25.0 will be used to assess the differences between groups after adjustment for confounding variables. We expect a shift in the diversity of the microbiota and associated increase in the butyrate levels and improvement in general mental health and sleep in those who receive Fibre -fix compared to those who receive control. In addition, the benefits of RS are likely to reduce IBS symptoms and improve gut health whilst on a low FODMAP diet, proposing a long-term dietary solution for those with IBS. The proposed mental health and sleep benefits may have a flow-on effect in terms of lowering the occurrence of other comorbidities, such as depression and work absenteeism which have economic costs, thereby lowering the burden on the healthcare system and reducing healthcare costs for those with IBS.

  • A study to investigate if melatonin can improve sleep in hospital after abdominal surgery.

    The primary purpose of this project is to determine whether the use of melatonin improves the quality of sleep in patients undergoing major abdominal surgery. Melatonin is a natural hormone secreted by the pineal gland. Melatonin when given at night works to promote sleep by helping to regulate the body's bio clock and sleep-wake cycles. It is well known that sleep quality in hospital is poor and can cause insufficient sleep which reduces natural immune function. Major abdominal surgery leads to the release of both pro-inflammatory and anti-inflammatory chemical in the blood.. Melatonin could be an effective adjunct medication not only to assist in improving sleep but to dampen the inflammatory response after surgery.

  • Cognitive behavioural therapy and hypnosis in the treatment of major depressive disorder: A randomised control trial

    The focus of this project is the treatment of adults with Major Depressive Disorder (MDD) using group psychotherapy. It will examine Cognitive Behaviour Therapy (CBT), an effective type of psychotherapy with outcomes comparable to if not better than medication. In spite of these results, only about 50% of depressed people improve with CBT, and many relapse. Over the years, much effort has gone into exploring ways to improve treatment outcomes for MDD with CBT. Drawing on past and current research, this project combines various components of CBT into a unique and somewhat shorter treatment package. This project aims to answer two key questions: 1. Does this 10 session CBT treatment, delivered in a group format, achieve comparable results with benchmark studies that have primarily used Behavioural Analysis, Cognitive Therapy or CBT treatment over more sessions? 2. Does CBT with the addition of hypnosis (CBTH) achieve better outcomes for MDD than CBT without hypnosis ?

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