ANZCTR search results

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

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31137 results sorted by trial registration date.
  • Oral Pilocarpine tablets for advanced cancer patients with dry mouth.

    This study will evaluate the feasibility and efficacy of pilocarpine on xerostomia for patients with cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with cancer and xerostomia Study details Participants in this study will receive both the interventional drug and placebo drug but in a random sequence. At the beginning of the study, Participants will receive 6 bottles of drug. 3 bottles contain placebo and 3 contain the drug pilocarpine. The 6 bottles will be taken randomly as instructed by the pharmacy over 18 days. Participants will not know which bottle has what drug. The drug will be taken three times a day for the 18 day trial. All participants will complete a diary which will provide information around dry mouth symptoms, and document any adverse events/side effects experienced. We hope that this drug and formulation will be able to help cancer patients in the future who suffer from the debilitating symptom of chronic dry mouth.

  • The Efficacy, feasibility and usability of using "Pain Check®" as a tool to assist family caregivers in assessing and monitoring the pain of their loved one's with severe dementia

    The study focuses on applying a new assessment technology to better detect and monitor pain in older people with dementia living in the community. Elderly people, particularly those with dementia frequently suffer from painful conditions that are poorly treated. This is usually because dementia makes it difficult for people to remember and tell their doctors or family carers of how bad their pain is or in some cases when or where pain exists. Although, tools exit to assess pain in people with dementia, they are often subjective, manually based and subsequently underutilised. For this reason, this study aims to introduce PainChek® as an App for smart devices to assist family carers in assessing and monitoring pain of their relatives with moderate-severe dementia. It is hoped that the findings of this study will contribute to better pain management among this community-dwelling vulnerable population.

  • Investigating the views of stakeholders (family carers, people with dementia and healthcare professionals) about applying a new assessment technology to better detect and quantify pain in older people with dementia living in the community

    Pain often goes unrecognised and under-treated in people with communication difficulties such as those with dementia. Although, tools exit to assess pain in people with dementia, they are often subjective, manually based and subsequently underutilised. PainChek® is an approved medical device in the form of a smart device App, which combines artificial intelligence and smart automation to identify and quantify pain in real time. The App has been validated and used for assessing pain in people with moderate to severe dementia. PainChek® works by using facial recognition technology and analysis to detect pain through facial muscle movements which indicate the presence of pain. A number of studies have reported that PainChek® (formerly known as ePAT) is valid, reliable and accurate in identifying pain in people with moderate to severe dementia living in aged care facilities. It has also been used to assess pain in community-dwelling people with dementia referred to Dementia Support Australia. However, to date its use by family carers of people with dementia, and by people with mild dementia as an aide- memoire have not been studied. The study will therefore focus on investigating the views of stakeholders (family caregivers, people suffering from dementia and healthcare professionals) about applying PainChek® to better detect and measure pain in older people with dementia and those living in the community. The results of this study will be used to adapt strategies to facilitate family carers of people with dementia to use PainChek® to assess and monitor the pain of their loved ones, and for people with dementia who may wish to use the application as a way to document their pain experience.

  • A randomised, double-blind, single-dose study to evaluate the pharmacokinetic, safety, tolerability, immunogenicity and pharmacodynamic profile of ISU305 compared to Soliris® (Eculizumab) in Healthy Male Volunteers

    ISU305 is being developed by ISU Abxis as a proposed biosimilar to eculizumab (Soliris® marketed by Alexion in the European Union [Soliris]). Soliris is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) or atypical haemolytic uraemic syndrome (aHUS), disorders associated with dysregulated complement activation.

  • 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

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