ANZCTR search results

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

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33646 results sorted by trial registration date.
  • The Prevalence of Central Sensitisation in a Pelvic Pain Cohort; a Pilot Study

    Central sensitisation is when normal sensation from an everyday experience such as light touch is increased to produce an abnormally painful response. This project aims to look at how common (the prevalence) central sensitisation is in women who have pelvic pain. It will also explore other factors that may be associated with a higher risk of central sensitisation, for example, a longer duration of pain, anxiety/depression or a history of other pain conditions e.g. fibromyalgia. The findings will improve the medical knowledge about the role of central sensitisation in the development and experience of pelvic pain. Participation in this project will involve the following: - completion of the consent form below - completion of the questionnaire which will ask about age, demographics, pain history and risk factors, including questions about sensitive issues such as pregnancy loss and abuse. The questionnaire will take about 14 minutes to complete and some of the questions may seem repetitive.

  • Effect of exenatide once weekly on gastric emptying in type 2 diabetes

    This study is designed to evaluate the effects of 8 weeks treatment with the glucagon-like peptide-1 agonist, exenatide (once weekly (QW)), on the rate of stomach emptying, glucose absorption and blood glucose and plasma insulin concentrations in type 2 diabetes. This is a randomised parallel designed study. Subjects recruited into the study who pass screening criteria will be randomised to receive exenatide QW or matching placebo. They will have a gastric emptying study performed using the gold standard technique (scintigraphy) at baseline and at 8 weeks. Immediately following the first gastric emptying study they will commence treatment with exenatide QW or Placebo, administered subcutaneously at weekly intervals. Glucose absorption, blood pressure, blood glucose and plasma insulin will be assessed during each of the gastric emptying measurements.

  • Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy

    Sunrrise Australia is the Australian arm of the Sunrrise Trial (Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy), a randomised controlled trial funded by the Research for Patient Benefit Program of the National Institute of Health Research UK. The UK trial is led by the Trainee Research Collaboratives in the West Midlands and North West Regions of England. Sunrrise Australia has full support from NIHR RfPB board, the UK trial leaders and the Clinical Trials Network Australia and New Zealand (CTANZ) This study tests whether a new type of active wound dressing can reduce rates of wound infection (surgical site infection, ‘SSI’) after emergency surgery on the abdomen. These dressings are Single Use Negative Pressure Dressings (SUNPD). They combine a sealed pad and suction to remove fluid from in and around the wound. Emergency abdominal operations are performed for a variety of life-threatening reasons, including bowel blockages, perforations, traumatic injuries and infections. At least 1 in 4 patients will be affected by an SSI after these procedures. These SSIs are painful, take longer to heal, extend hospital stays, incur significant extra costs, and can lead to ongoing wound care in the community. In an already unwell patient, development of an SSI can contribute to other major complications, including death. The trial is currently recruiting patients at 5 sites in the UK. It is expected that a further 25 UK sites will be opened by December 2019. With support from this grant, Australian sites will start recruiting in October 2019 The Australian study increases the power from 80% to 90%, reinforces the links in Surgical Research that have developed between the Research Collaboratives in the UK and Australia, and enhances surgical clinical research capacity in Australia by training a new generation of surgical trainees in trial methodology and conduct.

  • Emergence characteristics comparing Endotrachael tube vs Laryngeal Mask airway during nasal surgery with general anaesthesia using intravenous anaesthetic agents like propofol and remifentanyl.

    Traditionally ETT is used for the nose surgery for maintenance and protection of the airway during anaesthesia and recovery. There are only a few studies comparing reinforced laryngeal mask airway to ETT and these have shown similar efficacy in achieving the above functions. Reinforced laryngeal mask( RLMA) have been shown however to have a lower incidence of hoarseness, coughing during recovery in the post-anaesthesia care unit (PACU) and oxygen desaturation than patients treated with ETT . There is a paucity of literature on the use of RLMA and emergence characteristics. There are no trials examining the emergence characteristics of patients ventilated with ETT vs RLMA using remifentanil and Propofol. . We wanted to assess the RLMA for the suitability of its use in intranasal surgery (INS) and assess its safety during the surgery and emergence characteristics at the end of surgery.

  • Intermittent infusion of lidocaine, magnesium sulphate and ketamine in the treatment of neuropathic pain, Chronic Regional Pain Syndrome and fibromyalgia. A pilot study.

    Intermittent infusions utilising lidocaine, magnesium or ketamine are routinely used in the management of neuropathic pain and fibromyalgia. These three treatments are utilised for treatment of the same condition without any current evidence to compare efficacy or to guide clinicians in the most appropriate therapy for a given patient. The current paradigm in the management of pain utilises multimodal analgesia, in which analgesics with different mechanisms of action are used in combination to harness presumed additive (and hopefully synergistic) effects and limit dose related adverse effects. However studies of analgesics are only infrequently examined in combination, which leads to a lack of information regarding the additive nature of any effects (positive or negative). Within the Sir Charles Gairdner Hospital (SCGH) Pain Management Department, patients are admitted as day stay patients for brief (1-2 hour) infusions of either lidocaine or ketamine, usually repeated on a weekly basis for a series of three infusions. The aim of this pilot study is to assess the efficacy and tolerability of an infusion utilising a combination of lidocaine, magnesium sulphate and ketamine in the treatment of neuropathic pain, CRPS and fibromyalgia. Data will be used to identify appropriate doses and guide the creation of a later comparative study. This study will be an open label pilot study. 30 patients with peripheral neuropathic pain, CRPS or fibromyalgia will be recruited from the Pain Management Department at SCGH. Patients will receive four intermittent infusions utilising a combination of lidocaine, magnesium sulphate and ketamine. Patients will be assessed for intra-infusion adverse effects and on a fortnightly basis for 6 weeks and then at 3 months following the final infusion. Data will be collected via phone interview as well as utilising the ePPOC questionnaire which includes multiple pain measures (BPI, DASS21, PSEQ,PCS, GRoC and medication usage) and is routinely used in the Pain Management Department at SCGH to assess efficacy of therapy. Following completion of the study, data obtained along with data from a prior audits of lidocaine and ketamine infusions for the treatment of neuropathic pain will be used to design a double blind comparative study.

  • The Role of Fistula-tract Laser Closure in the Management of Perianal Fistula (FiLaC)

    The research project is testing a new treatment for perianal fistula. The new treatment is called Fistula-tract Laser Closure (FiLaC), produced by Bio-litec ®. This treatment is approved by the Therapeutic Goods Administration for treatment of this condition. The aim of this study is to assess the efficacy of FiLaC in treating patients with perianal fistula disease. This includes success rate of the treatment, associated pain, and return to normal daily activities post-operation.

  • The Role of Oral Metronidazole in the Management of Post Haemorrhoidectomy Pain

    We are planning on performing a double-blinded randomised controlled trial (RCT), investigating the role of oral metronidazole in the management of Post Open Haemorrhoidectomy pain. Haemorrhoidal disease is a common benign condition, with conventional open haemorrhoidectomy remaining the gold standard for treatment. The main post-operative complaint is pain. Various methods have been used to optimise analgesia post-haemorrhoidectomy. The most widely used pharmacological agent is metronidazole, typically administered orally. However, the overall quality of previous studies investigating this have been few in number and generally of poor quality. It is common practice however, for the majority of surgeons both nationally and internationally to administer a prophylactic course of oral metronidazole to decrease post haemorrhoidectomy pain. We hope to run our own RCT, double blinded, to assess whether oral metronidazole really does decrease post-operative pain. Patient will be either randomised to a seven day course of oral metronidazole (400mg TDS) or placebo. Patients will be followed up for 6 weeks, with the use of a 10-point Visual Analogue Scale (VAS) to assess their pain at various time intervals post-operatively.

  • Tetrahydrocannabinol for cancer-related anorexia

  • Active Women over 50 Online: a pilot trial

    We have designed a simple intervention aimed at increasing physical activity in females aged 50+. Stage 1 of the Active Women over 50 project involved a pilot RCT (ACTRN12617000485336) to test the impact of a one hour face-to-face education session about physical activity, as well as access to follow-up support strategies (goal setting, email prompts) for promoting behaviour change. In the Active Women over 50 stage 1 pilot RCT (n=130) the education session was well-received among university and hospital employees, with 100% of attendees subsequently investigating the suggested physical activity resources further (e.g. physical activity websites, local facilities, Fitbit device) to increase activity. In order to broaden the reach of the program and to enable implementation to a more varied population of women from different geographical areas, we now plan to develop and evaluate the impact of an online resource in phase 2 of the Active Women over 50 project. Active ageing is at the core of this highly innovative project that targets women aged 50 years and older. To our knowledge there currently exists no other online resource that specifically targets physical activity information and resources in a way that is relevant to the needs of women aged 50+ years. Women in this age group have unique barriers to becoming more active and hence a targeted and supported approach to ensure behaviour change is sustainable is particularly important. Women aged 50+ years may struggle to increase physical activity participation due to factors such as lack of time, carer responsibilities, demands of work, chronic health conditions, chronic pain and disability. By taking a tailored and supported approach to the provision of physical activity information, our innovative project has the potential to substantially increase physical activity participation in people aged 50+. The use of video case studies of real women who have managed to become active in the face of many barriers is a particularly innovative aspect of our program since it provides relevance and familiarity to the target audience. This approach also allows for the targeting of key messages to a broad range of women 50+ from all geographical areas and socioeconomic backgrounds. This project aims to assess the feasibility and acceptability of an online physical activity behaviour change resource with follow-up support and to pilot test the proposed methods for a planned large RCT to assess the impact of the intervention on physical activity among women aged 50 years and over.

  • Partnering with Parents: Building quality relationships that benefit children

    Partnering with Parents is a practice support system designed to embed evidence-based approaches to working in partnership with parents in an early childhood education and care (ECEC) service. The aim is to create an environment welcoming of and responsive to parents as well as strengthening educators’ skills and confidence to interact with parents in a way that is supportive of their parenting. With the support of the Department of Health and Human Services (DHHS), the Parenting Research Centre (PRC) propose to evaluate whether Partnering with Parents is effective in achieving its objectives via an experimental trial design - a Cluster Randomised Controlled Trial (cRCT). PRC plan to support the implementation of Partnering with Parents within 14 sites throughout 2019 and evaluate both process and outcomes via an experimental trial. Our research questions are: • To what extent do staff, including educators, educational leaders and Practice Coaches use components of the practice support system? That is, which components are used, by whom, and how often? • To what extent do staff, including educators, educational leaders and Practice Coaches find components of the practice support system useful? • Following intervention, and compared with wait list participants, to what extent are changes seen in educators’: measures of quality of parent-educator relationships, skills and confidence in communicating with parents, and referral activities? • Following intervention, and compared with wait list participants, to what extent are changes seen in parents’: measures of quality of parent-educator relationships, satisfaction with communication at the centre, perceptions of the relational environment at the centre, help-seeking after advice from educators at the centre, and parenting confidence? • What process or demographic factors mediate or moderate the results obtained? • To what extent do parents’ and educators’ responses correlate when they fill in common measures? We will collect data online from ECEC staff and parents at three time points: pre, post and three months following the intervention. We will collect feedback from Practice Coaches after they are trained to deliver Partnering with Parents.

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