ANZCTR search results

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

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32114 results sorted by trial registration date.
  • Transperineal prostate biopsy under local anaesthetic: an analysis of cost, efficacy and patient tolerability in Australia

    The aim of this study is to assess the tolerability, safety and cost of transperineal prostate biopsy techniques in men with suspected prostate cancer. Who is this for? You may be eligible to participate in this study if you are scheduled to undergo a transperineal prostate biopsy for suspected prostate cancer, or as part of active surveillance for prostate cancer. Study details Participants who consent to participating in this study will undergo a transperineal prostate biopsy with Penthrox and local anaesthetic by a qualified Urologist at a public hospital. We will assess your pain levels during the biopsy with a visual analogue scale survey and also analyse rates of cancer detection, perioperative complications and costs. We will do this by retrospectively comparing to cohorts of patients who have undergone transperineal biopsies at the same health service prior, under general anaesthetic. Our objective is to demonstrate that transperineal prostate biopsies under local anaesthetic are comfortable for the patients, safe, and just as accurate as those performed under general anaesthetic. Further, we aim to demonstrate that it is more efficient and cost effective, therefore resulting in reduced healthcare costs and improved accessibility with less wait times for patients requiring a prostate biopsy.

  • An On-track Trial to Assess Driving from Medical Cannabis

    The CAN-TRACK study is a closed-circuit track trial designed to assess the impact of medical cannabis on driving performance. This study aims to evaluate the cognitive, behavioural, and driving-related risks associated with the use of THC-containing medical cannabis in patients who have been using their prescribed product containing 2mg or more of THC for at least 3 months. The findings are expected to provide valuable insights into how medical cannabis influences driving safety, informing public health policies and road safety regulations.

  • Penthrox vs nitrous oxide for painful emergency medicine procedures

    Timely provision of analgesia in the emergency department is often challenging, especially during periods of high patient demand. This has been exacerbated by ongoing staff shortages since the COVID-19 pandemic. Although several analgesic options already exist in the emergency department setting, not all clinical scenarios are well catered for. In particular, patients who are required to undergo a painful procedure in the emergency department, such as suturing, wound debridement or reduction of a fracture, often have to wait for a considerable length of time due to lack of an available treatment space with a nitrous oxide wall outlet, inadequate staffing to provide a second clinician or inadequate fasting. Penthrox provides an alternative that may alleviate some of these issues, allowing for more timely administration than nitrous oxide and subsequently a shorter length of stay. Although a number of studies have been published comparing Penthrox with placebo, there are no good quality head-to-head studies that directly compare Penthrox with nitrous oxide.

  • Addressing health equity by screening for neurodevelopmental concerns in primary healthcare

    Screening children and adolescents at-risk of neurodevelopmental concerns in primary healthcare starts them on early pathways of support and catches those who might otherwise fall through service gaps. To assist health care decisions and help plan treatment pathways, we spent 5 years co-designing the Tracking Cube: a culturally responsive, tiered neurodevelopmental screening approach integrated with child well-health checks. After pilot implementation at an Indigenous remote primary health service, neurodevelopmental concerns were 4 times more likely to be identified using the Tracking Cube compared to usual care. Promisingly, specialist referral numbers did not significantly increase, and specialists reported receiving more appropriate referrals. This project will use a stepped wedge cluster randomised trial to measure the effectiveness of the Tracking Cube at diverse primary healthcare partner sites. The primary hypothesis is that use of the Tracking Cube will increase the identification of neurodevelopmental concerns. Secondary hypotheses are that the Tracking Cube will increase identification of children at-risk of neurodevelopmental disorders, increase follow-up of these chidren in primary care, and increase the appropriateness of referrals to specialists. Outcomes from this project will inform best practice around child and adolescent screening and also drive the Indigenous health equity agenda nationwide.

  • A pilot study to assess the utility of a ‘sterile cockpit’ on the quality of the Surgical Ward Round

    The aviation industry has been successful in mitigating human error using a ‘Sterile Cockpit’ to reduce interruptions and non-essential activities. The aim of this study was to therefore implement a ‘Sterile Cockpit’ into the surgical ward round, with aims to improve patient outcomes, satisfaction, and documentation of care. The hypothesis of this study is that the Sterile Cockpit intervention will improve the accuracy of documentation of patient care, therefore reducing length of stay, and improving patient satisfaction.

  • The Effect of Translated information to improve consent for surgery in non-English speaking patients: a randomised controlled trial

  • An evaluation of Hello Sunday Morning’s online alcohol behaviour change programs and services for the community

    We will conduct a pilot (using a randomised controlled trial approach) to evaluate the feasibility, acceptability, and effectiveness of a new behaviour program, called Hello Change, to ensure it meets the needs of Hello Sunday Morning members. Validated screening tools will be used to measure alcohol use (AUDIT-C) and psychological wellbeing (K6). We will also examine the demographic and characteristics of Hello Change users to gain a better understanding of who is utilising the program (satisfaction survey). The hypothesis of this study is that the Hello Change program will (1) have high uptake, (2) attract high satisfaction and recommendation ratings, and (3) reduce alcohol consumption and improve psychological wellbeing in those seeking to reduce their intake.

  • A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of OLX75016 in Healthy Volunteers and Patients with Non-Alcoholic Fatty Liver Disease.

    OLX75016 is being developed by OliX Pharmaceuticals as a treatment for patients with treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis. This study will evaluate the safety and tolerability of single and multiple ascending doses of OLX75016 in patients with non-alcoholicfatty liver disease (NAFLD). This study will be conducted in 2 parts : Part A (Single ascending dose) and PartB (Multiple ascending dose). Up 20 patients with NAFLD are expected to be engaged with the study for up to 87 days in Part A or up to 172 days in Part B of the study. OLX75016 and matching placebo will be administered as SC injections in the abdominal region in this study. Part A- Following confirmation of eligibility, patients with NAFLD will be randomized to receive OLX75016 or placebo prior to dose administration on Day 1. All patients with NAFLD will be confined to the clinic until the completion of all safety/tolerability and PK assessmentson Day 3. Participants will be required to return to the clinic for additional outpatient safety/tolerability assessments on Day 4, 7, 14, 28, 42, 84, 112, 140, 168, 196 and 224. Participants will be discharged from each visit following completion of all safety and PK assessments, the end of study (EoS) visit will be on Day 224. Part B - Following confirmation of eligibility, patients with NAFLD will be randomized to receive OLX75016 or placebo prior to dose administration on Day 1 and Day85. All patients with NAFLD will be confined to the clinic from day prior to dosing until the completion of all safety/tolerability and PK assessments 3 days post-dose and will be discharged following completion of all safety and PK assessments on Day 3. Patients with NAFLD will be required to attend the clinic on Days 4, 7, 14, 28 and 56 for safety and tolerability assessments. Patients with NAFLD will return to the clinic for a second confinement period from Day 84 to Day 87, with the second dose of OLX75016 or placebo administered on Day 85. NAFLD patients will be required to attend the clinic on Days 88, 91, 98, 112, 140, 169 for safety and tolerability assessments before the EoS visit on Day 253. It is hoped that the information learned from this study will help the sponsor learn more about how best to treat patients suffering from NASH and liver fibrosis in future. This research may also give rise to new or improved improvements.

  • The development and pilot evaluation of an online mental health training program for managers in the aged care sector

    This research aims to evaluate the feasibility, acceptability and preliminary efficacy of a mental health training program for managers in the aged care industry. This skills-based mental health training program has been shown to be effective in other occupational groups and has been tailored, alongside representatives from the aged care workforce, to suit the needs of those working in the aged care sector. The efficacy of the program will be evaluated through a pre-post intervention pilot trial design which aims to address the following research questions: 1. Is the delivery and content an adapted version of a previously evaluated manager training program tailored to managers working in Aged Care meeting the needs for this group? 2. Does training managers through a tailored workplace mental health program increase a) their knowledge in how to best support the mental health needs of the staff they supervise, b) their confidence to support the mental health needs of the staff they supervise and c) their application of responsive and preventive strategies to minimise psychosocial hazards in the workplace for the staff they supervise?

  • Identifying rehabilitation associated predictors of patient satisfaction following primary total knee arthroplasty: a survey study

    Despite continuous advancement in surgical technique and pain management, many patients remain dissatisfied following their total knee arthroscopy (TKA). From a patient-centred perspective, a TKA is only successful if the patient is satisfied with the outcome. In recent years, many studies have described the significance of patient expectations, level of function, post-operative pain levels, surgical techniques, and comorbidities to patient satisfaction. While current literature often mentions a correlation between patient satisfaction and rehabilitation, there is minimal comprehensive research on the topic. This study aims to identify the surgical and physiotherapy predictors of patient satisfaction during the rehabilitation process. These findings may play a role in implementing changes to clinical practice and thus, improving patient satisfaction in Gold Coast Health facilities with the potential for broader impact across QLD Health.

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