ANZCTR search results

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

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30819 results sorted by trial registration date.
  • Stepped Care in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study

    This research project is based at Eating Disorders Victoria (EDV) and embeds a master of clinical psychology placement program for postgraduate psychology students within a research program examining evidence-based eating disorder assessment and treatment. (Master Research Agreement attached) This is a pilot and feasibility RCT with two primary aims: (i) to explore the viability of running a full RCT to compare treatment efficacy and cost effectiveness of a stepped-care model of eating disorder treatment, specifically comparing two interventions; Cognitive Behaviour Therapy (CBT-E) and Guided Self Help (GSH); and (ii) to explore the feasibility of providing specialised training in eating disorder treatment and access to treatment via a community-university partnership that embeds professional psychology training in an ongoing research and treatment program. It is expected that eating disorder symptoms will be significantly reduced from pre- to post-treatment in both CBT-E and GSH. It is also expected that those allocated to the CBT-E group will have significantly lower eating disorder symptoms post-treatment compared to those allocated to GSH.

  • Assessing whether testing of rectal swabs is as accurate as bulk faeces testing in diagnosis of bacterial infections.

    We are verifying if rectal swabs are as accurate as builk faeces testing in routine clinical care. We hypothesise that these two tests are equally as accurate and it would mean that it is easier to obtain medical tests for gastrointestinal organisms during routine clinical care.

  • From minds to mindsets: drowning interventions and a pathway to the population-scale impacts

    The research team partnered with Surf Life Saving Australia (SLSA), Life Saving Victoria (LSV), and local council to co-design a learning-focused intervention. Learning had been identified through a pilot study conducted in 2021, in which beachgoers requested skills and opportunities for learning from the beach safety sector. The themes and best practices to be covered in the lesson were drawn from the pilot study, the literature, and then discussed amongst the research team and representatives of the risk sector, including those overseeing lifeguards in the case study region. The lifeguards to participate in the lesson were invited to contribute to these discussions but, being predominantly young university students, were unavailable. A finalized list of 19 actions were identified and incorporated into development of the lesson and into the codebook for measuring impact.

  • A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE50 0134 in Healthy Volunteers

    This is A double-blind, placebo-controlled, First-in-Human Study study to assess the safety ofZE50-0134, and how this drug acts in the body in healthy volunteers. ZE50-0134 may be indicated for use in patients with chronic lymphocytic leukaemia (CLL), but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of ZE50-0134 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of ZE50-0134 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of ZE50-0134 that can be administered safely without causing severe reactions. Once the dose of ZE50-0134 has been determined in healthy volunteers, a trial investigating the efficacy of ZE50-0134 as a treatment for patients with CLL may proceed.

  • The Neonatal Ventilation using Tomography (NEOVENT) Study

    Respiratory disease is the most common reason for admission to a NICU. Unfortunately, our understanding of how many respiratory therapies used in the NICU help babies lungs is poor. Broadly, we will create a large registry of lung function data during common NICU respiratory events and diseases. By doing so we will be able to address some of the uncertainties in clinical care for babies born with respiratory failure, specifically how best to determine optimal levels of respiratory support and how to guide common respiratory interventions such as extubation and surfactant therapy. We hypothesise that by generating a greater understanding of the relationship between a baby's lung disease and NICU respiratory care we will provide the tools to allow clinicians to improve respiratory care.

  • PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics Education & Implementation Program for Pharmacists

    This is a substudy of the PRECISION-ITS trial. This study involves developing and evaluating a pharmacogenomics education/implementation program for pharmacists in Australia, The program will be developed by a multidisciplinary working group consisting of healthcare professionals, consumers and patients/carers with lived experience. Surveys assessing the knowledge, attitudes, perceptions and acceptability of pharmacogenomics amongst consumers and healthcare professionals in the adult and paediatric oncology setting will be used to inform the program's design. Who is it for? .You may be eligible to complete the survey(s) if you have received or cared for an adult or child who received treatment for cancer in Australia and are aged 15 years or above; or are a healthcare professional working in adult or paediatric oncology within Australia. Study details The program will be delivered to pharmacists at sites participating in the primary PRECISION-ITS trial. You may be eligible to participate in the program if you are a pharmacist at a regional Victorian hospital that is participating in the primary PRECISION-ITS trial. The program will focus on pharmacogenomics in adults receiving systemic anticancer therapies and implementing a pharmacogenomics service at participating sites in regional Victoria. The program will be evaluated by implementation science frameworks and participant end-user surveys. It is hoped that this research project will: address pharmacists' education needs in pharmacogenomics and establish a framework for wider implementation to other healthcare professionals and craft groups. It is hoped that this program will also facilitate pharmacogenomics knowledge translation into clinical practice, providing opportunities for rapid pharmacogenomics workforce capacity building, scalability and community acceptance beyond the trial.

  • Actual-use of CP1110 Sound Processor, CP1175 Sound Processor and associated system components in experienced adult CI1000 Series cochlear implant recipients.

    This is a pre-market, prospective, single-site, open-label, within-subject, non-randomised interventional study of acceptance of the CP1175 and CP1110 Sound Processors through use with adult cochlear implant recipients in real world scenarios. The investigational medical devices include an off-the-ear sound processor, a behind-the-ear sound processor, used in conjunction with investigational versions of fitting software, the Nucleus Smart App and a software measuring postoperative implant function. The objectives of the investigation are to collect device and procedure-related deficiencies to optimise clinical care for recipients of the investigational CI1000 Series cochlear implants.

  • Brain & Body Protein Powder and Sleep in Older Adults

    The aim of the present study is to investigate the effects of Brain and Body protein powder on sleep quality and other health-related outcomes—including cognition, mood, brain activity and biochemical parameters— in ageing adults 55-to-75 years of age. The Brain and Body protein powder may have the potential to affect benefits in the outcomes noted. This will be an 8-day randomised, double-blind placebo-controlled trial where 40 participants will be recruited. The trial will consist of two arms: 1) Dairy-based protein powder (Brain & Body Protein Powder) and 2) Rice starch placebo control.

  • A Randomised, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous, Ascending Single Doses of AP13 in Healthy Adults

    This is a first-in-human, single-centre, randomised, double blind, ascending single dose study to assess the safety and tolerability of AP13 and how this drug acts in the body in healthy volunteers. AP13 may be indicated for use in patients with pulmonary hypertension, but a trial of the drug in healthy volunteers is needed before trials in patients with pulmonary hypertension can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of AP13 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with pulmonary hypertension.

  • Gallium Imaging Pilot Study in Metastatic Melanoma

    This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and have been diagnosed with locally advanced or metastatic melanoma. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. An 18F-FDG-PET and CT scans will be required for assessing participant eligibility, however if these scans were performed as part of standard of care prior to the date of consent but are within 28 days of the Day 1, they may not need to be repeated. Each participant's circumstances will be assessed by a study investigator and participants will be advised if scans need to be repeated. If eligible, participants will receive a single dose of 68Ga-A9T-3202 via intravenous injection, and then undergo 4 whole body PET-CT scans at set timepoints on the day of administration. Participants will then complete an End of Observation visit (one day post IP administration) to check participant safety and tolerability of 68Ga-A9T-3202. It is hoped this research will demonstrate that 68Ga-A9T-3202 is safe and well tolerated by patients with metastatic melanoma, and provide more accurate staging and treatment response evaluation when compared to the current standard of care PET/CT imaging.

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