ANZCTR search results

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

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33057 results sorted by trial registration date.
  • Does guideline-based dosing of beta lactam antibiotics and vancomycin achieve the target drug concentrations more than therapeutic drug monitoring-based dosing in critically ill patients? (GUIDE TRIAL)

    This study aims to investigate ‘guideline based antimicrobial dosing’ in terms of pharmacodynamic target attainment and clinical outcomes and compare these findings to a matched cohort of patients receiving Therapeutic Drug Monitoring (TDM) based dosing. A sample size of 150 ICU patients meeting the inclusion criteria is required. This study is a single centred, prospective, observational study in critically ill patients admitted to the ICU with infections treated with the study antibiotics. All patients admitted into the ICU over a 12 month period who meet the inclusion criteria are consider for inclusion. This research will fill a gap in contemporary studies in terms of describing the achievement of pharmacodynamic targets of guideline based antibiotic dosing compared to a matched cohort of TDM-based dosing.

  • Evaluating fibres on gut health in Irritable Bowel Syndrome

    IBS is a functional GI disorder that causes long-term GI symptoms that reduce quality of life. Dietary management of IBS using the low FODMAP approach can effectively manage symptoms, but may indirectly compromise other aspects of gut health, including bowel habit and the gut bacteria. We have identified two types of dietary fibre whose functional properties may address these potential consequences and optimise dietary management of this condition. The aim of this clinical is to provide the low FODMAP diet to participants with IBS, with or without these fibres, in order to investigate their effects on GI symptoms, GI function and the gut bacteria.

  • Use of Smart Phone Technology in Predicting Liver Viability Pre Biopsy

    Currently transplant during organ procurement specially trained theatre technicians take photos of the potential donor liver prior to aortic cross clamp and following reperfusion. These pictures are then sent to the transplant surgeon, transplant coordinator, liver pathologist via secure communication and stored on the liver database. In addition a biopsy is sent to the lab to confirm viability. On the basis of these pictures the surgeon either decides to go ahead with surgery or wait for the biopsy. An operating theatre is placed on hold from the time the team leave for organ retrieval until the biopsy results come back at which point they either proceed with the transplant or cancel it. This process can take several hours during which time each person who has seen the photo claims to be as accurate as the eventual laboratory result in predicting organ viability, organ age and organ fat content. We would like to create user response curves to see if there is a correlation between health care provider groups and their ability to predict organ viability in liver transplant

  • Randomized Controlled Trial of the impact of pain relief checklists on pain outcomes in patients after a hemorrhoidectomy

    A major concern regarding hemorrhoidectomy is the considerable post­-operative pain experienced by patients for up to 14 days after surgery. Current pain management after a hemorrhoidectomy involves a 2 week extensive course of analgesics. However, a lack of adherence to such an extensive treatment plan may result in suboptimal pain relief. This randomised controlled trial aims to determine if patients who receive a checklist of their prescribed medications which they must tick off each day (checklist group) experience better pain relief than patients who receive the same medications without a checklist (control group). We hypothesised that participants in the checklist group would experience better pain relief compared to the control group due to the checklist helping them keep track of what time and dose they need to take their medication as well as what they have already taken. We intend for the results of the trial to be used as a starting point for the implementation of effective non-pharmacological adjuncts to pharmacological pain management after hemorrhoidectomies.

  • Establishing fitness to drive protocols following elective day surgery

    Abstinence from driving a motor vehicle is recommended for 24 hours following procedural sedation. Despite this, as many as 1 in 10 people drive in the first 24 hours after day surgery, and nearly the same amount report driving home immediately after they have been discharged form hospital. Drivers are often guided by their treating physicians to abstain from driving until ‘physical and mental recovery is compatible with safe driving’, however, there is no clear standard on what constitutes compatibility with safe driving, nor what benchmark is considered acceptable in terms of physical and mental recovery. This project aims to gather vital information about the performance-based effects of sedating-type medications on driving performance to provide treatment-relevant data to inform postoperative driving restrictions and inform patient discharge procedures.

  • Testing a new smart phone app (“Smart Track”) for adults with experience of addictive behaviour(s): Exploring the experience and attitudes of SMART Recovery participants and facilitators about using the app to self-monitor progress

    Routine Outcome Monitoring (ROM) refers to the regular completion of questions that assess change over time. ROM can help clients see how they are progressing, and also allows services to see how/ whether they are useful. Importantly, ROM can improve client outcomes and is common across a range of treatment settings. Although mutual support groups are a common an important source of support for people with experience of addictive behaviour(s), ROM is not routinely used. To address this gap, in the first part of this study, we worked with SMART Recovery group members and facilitators to develop a Smart Phone Application (app) for this purpose: “Smart Track”. In this part of the study we are interested in understanding a) whether Smart Track is something that SMART Recovery group members are willing and/ or able to use b) How people feel about it (including what they found to be useful, less useful and any suggestions for improvement) c) How expensive it is to develop and maintain d) How the Smart Track items compare to the l onger/ full versions of the questionnaires

  • Building bone from blood: The relationship between Vitamin D and Circulating Osteoprogenitor (COP) cells – A pilot study

    This project is investigating the relationship between vitamin D levels, and a recently discovered stem cell called a circulating osteogenic precursor (COP) cell. COP cells are stem cells found in the circulating blood, with the capacity to form bone as well as other tissues such as fat, muscle and cartilage. It is hoped that these cells might be used to treat and manage a range of bone diseases such as fractures and osteoporosis (brittle bones). Vitamin D is known to be important in maintaining bone health, and this trial hopes to uncover whether COP cells play a role in this. This pilot study aims to help us to understand the relationship between vitamin D and COP cells, so that we can plan and run a successful large trial in the future. To achieve this, we want to recruit 30 healthy volunteers with different vitamin D levels, from low to normal. Then we will give half of them a large initial dose of vitamin D, and the other half a placebo pill. Everyone will then get a small vitamin D supplement for 6 weeks. We will measure their COP cell numbers every 3 weeks. We will look for changes in COP cells in those receiving different treatments and also with different starting vitamin D levels. There are no new medications or procedures being trialed in this study, so we expect it to be very safe.

  • Preventing postnatal depression and anxiety in new mothers using telephone peer support: a randomised controlled trial.

    Postnatal depression (PND) is a major public health issue, with potential serious adverse consequences for a mother’s health and that of her infant and family. In Australia, 17% of mothers experience depression; an estimated 53,000 women are affected each year, a significant health and economic burden. We aim to conduct a multi-site, two arm randomised controlled trial of telephone peer support (mother-to-mother) to prevent PND among new mothers. We are recruiting 1060 new mothers assessed as at increased risk of PND (i.e. score >9 and = 20 on the Edinburgh Postnatal Depression Scale) for this trial. Recruitment at the routine 4-10 week postpartum Maternal and Child Health (MCH) visit, from two local government areas commenced in May 2019, but discontinued in December 2019. Women are currently being recruited from the postnatal wards of two hospitals. At recruitment, women will be randomly allocated to the control group (standard care) or the peer support (intervention) group. Mothers allocated to peer support will receive proactive telephone-based support from a peer volunteer (mothers who have a history of and recovery from PND), in addition to all standard community services up until six months postpartum. Outcome data will be collected at 6 month postpartum. We will test if women allocated to telephone peer support are less likely to have depressive symptomatology, defined as a score >12, on the Edinburgh Postnatal Depression Scale (17% vs 25%) 6 months after the birth.

  • Study of Ketamine for Youth Depression

    The primary aim of this research project is to determine if a 4-week course of low-dose subcutaneous ketamine is an effective treatment for young people (males and females aged 16-25 years) with moderate-to-severe depression. Participants will be randomised to receive either low-dose subcutaneous ketamine or a blinded control treatment that is therapeutically inactive (midazolam), given once a week for 4 weeks. Change in depression scores will be assessed at the end of the treatment phase at week 4, with further assessment at weeks 8 and 26 to assess whether treatment effects are sustained. We hypothesise that ketamine will be an effective treatment for moderate-to-severe depression in young people.

  • Optimising patient weight management prior to joint replacement to improve outcomes: a feasibility study with embedded qualitative component

    - Obese people undergoing total knee or hip arthroplasty (replacement) surgery for osteoarthritis have worse outcomes (complications, less favourable longer-term recovery) compared to non-obese people. - We hypothesise that a low inflammatory diet will be feasible and will encourage weight loss and will lower signs of inflammation in people with knee or hip arthritis awaiting joint replacement (arthroplasty). - We will test our hypothesis using a quasi experimental study design [Before (control) and after (intervention) study]. - Little is known about barriers and enablers to weight loss ad a low inflammatory diet amongst obese people with end-satge arthritis and from culturally and linguistically diverse backgrounds. We aim to explore this through individual and focus group interviews.

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