ANZCTR search results

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

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30809 results sorted by trial registration date.
  • The Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) Project

    The Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) Project aims to enable older adults to effectively engage with Advance Care Planning (ACP), in the home care setting. Advance care planning is the process by which older adults, or people who are experiencing chronic disease, terminal illness (including cancer) and/or are at risk of dementia and similar conditions can provide instructions to their carer/s about their main preferences and goals for future care, should they reach a stage where they may not be able to make these decisions on a day-to-day basis. The EARLI-comm project focuses on enabling diverse adults with diagnosed life-limiting conditions and/or emerging frailty to express their values, goals and preferences regarding future care and treatment. Who is it for? You may be eligible for this study if you are aged 45 years or older, you have been diagnosed with a life-limiting neurological condition (dementia, Parkinson's disease, Huntington's disease, Motor Neurone disease, mitochondrial disease) or Human Immunodeficiency Virus (HIV). Adults (aged 18 years or older) who also provide support/care to participants who meet these criteria will also be eligible to participate and provide their feedback on the EARLI-comm program. Participants who meet these criteria and have been diagnosed with cancer will also be eligible. Study details Participants who choose to enrol in this study will be allocated by chance (similar to flipping a coin) to one of two groups. The first group will receive the EARLI-comm program which involves meeting with a member of the research team every fortnight for up to 12 weeks. Each meeting is expected to last up to 1 hour and these participants will be guided through the ACP process and given an opportunity to discuss their goals and preferences with members of their aged care and primary care (GP or other specialist) teams. The second group will continue with their usual care for 12 weeks. After the 12 weeks of follow-up has been completed for both groups, participants who were allocated to the second group will be able to commence the EARLI-comm program if they wish. The overall duration of participation in this study will be 12 weeks from the date of enrolment. It is hoped that this study will determine whether this program is effective in helping older adults in the home care setting to be clearer about their values, preferences and plans for the future, while strengthening relationships and improving wellbeing.

  • Vestibular neuromodulation for the treatment of persistent pain: An open label case series

    We aim to collect data on pain and functional benefits following 6 sessions of caloric vestibular stimulation (CVS) in up to 100 patients with persistent pain (PP). We will gather open label case series data of CVS pain modulation in these PP patients to justify and inform design of a future double blind randomised controlled trial (DB-RCT). We hypothesise that 6 sessions of CVS will induce pain reduction of at least 20% magnitude, for at least 6 weeks duration, in at least 20% of enrolled PP patients. We further hypothesise, based on previous data, that allodynia (pain in response to a non-painful stimulus) will be particularly susceptible to improvement following CVS.

  • Randomised controlled trial comparing complication rates of magnetic ureteric stent and stent on extraction strings for kidney stones

    Comparing the complication rate between 2 different types of ureteric stent (Magnetic stent vs stent on extraction strings) which are used during the surgical treatment of kidney stones. We believe that magnetic stent may have less complication and side effects than the stent on extraction string.

  • An ascending, single and multiple dose(s), double-blind, randomized, placebo controlled study assessing the safety, tolerability, and pharmacokinetics of ov329 in healthy male and female participants

    OV329 [(S)-3-amino-4-(difluoromethylene) cyclopent-1-ene-1-carboxylic acid hydrochloride salt] is a gamma aminobutyric acid (GABA) aminotransferase (GABA-AT) inhibitor that is being developed as an antiseizure medication for rare seizure disorders in adults and pediatric patients. Part A will consist of up to 5 cohorts, comprising 8 participants each. Dosing will be initiated at 1 mg/day. Subsequent cohorts will be dosed as recommended by the Data Review Committee (DRC) based on the safety, tolerability and PK of OV329 from the previous cohort. Target engagement measured by MRS will also be considered in assessing the potential dose escalation as the dose will not be increased by more than 50% relative to the previous cohort if GABA levels are 2-fold increased. Part B will consist of 2 planned cohorts comprising 8 participants each, using 2 and 3 mg doses of OV329. Dosing will be initiated at 2 mg/day. Subsequent cohorts will be dosed as recommended by the DRC based on the safety, tolerability and PK of OV329 from the previous cohort (based on review of the Day 30 data, including ophthalmological assessments) and not to exceed a Cmax of 27 ng/mL and/or an AUC of 32 ng*h/mL. Participants will be dosed for a total of 7 days.

  • Does the label given to a low-risk prostate lesion influence management choice in patient partners?

    This study aims to explore whether an alternative label used to communicate a hypothetical low-risk prostate cancer diagnosis influences management choice and level of anxiety among partners of those with prostates. Who is it for? You may be eligible for this study if you are the partner of an adult with a prostate who does not have a history of prostate cancer. Study details Participants will be randomly assigned randomised to receive one of three hypothetical scenarios about the diagnosis of a low-risk prostate cancer received by their partner. Each group will be presented with a different diagnostic label. Within each scenario arm, participants will be further randomised to receive either limited information about their partner's diagnosis and management options, or comprehensive information. We will then survey participants about their preferred choice of management for their partner's diagnosis, their level of anxiety about that diagnosis and their level of anxiety about that management choice. It is hoped that this study will help provide additional understanding on whether labels and provision of risk information will modify any effects of labels used for a low-risk prostate cancer diagnosis.

  • Does the label given to a low-risk prostate lesion influence patient management choice?

    This study aims to explore whether an alternative label used to communicate a hypothetical low-risk prostate cancer diagnosis influences management choice and level of anxiety among men in Australia. Who is it for? You may be eligible for this study if you are an adult with a prostate who does not have a history of prostate cancer. Study details Participants will be randomly assigned randomised to receive one of three hypothetical scenarios about the diagnosis of a low-risk prostate cancer received by themselves. Each group will be presented with a different diagnostic label. Within each scenario arm, participants will be further randomised to receive either limited information about their diagnosis and management options, or comprehensive information about their diagnosis. We will then survey participants about their preferred choice of management for that diagnosis, their level of anxiety about that diagnosis and their level of anxiety about that management choice. It is hoped that this study will help provide additional understanding on whether labels and provision of risk information will modify any effects of labels used for prostate cancer diagnosis.

  • Use of consumer smart wearable devices to detect early changes in physiological measures (heart rate, respirations and temperature) following vaccination before symptomatic onset of response to vaccine.

    Following the global COVID-19 pandemic, detecting viruses and infection symptomology has been important in minimising the spread of the infection but also to detect the early onset of infection in the body. This study focuses on using physiological measures, heart rate, respiration rate, sleep and temperature obtained from various non-invasive off the shelf consumer wearables (e.g., smart watches) to assist in potentially detecting the early signs of infections. Not only is this important to stop the spread of viral infections, but it could also provide insight in detecting the common cold or flu. As the spread of sicknesses can greatly affect people’s livelihood and productivity in various fields including but not exclusive to settings such as health care and the defence force, where work is 24/7 this study aims to use off the shelf consumer wearable devices (e.g., smart watch) to explore this.

  • Just what I wanted to hear. Evaluating reassurance delivered to patients with spinal pain by either a Physiotherapist or medical officer during consultation in an orthopaedic spinal clinic.

    This observational study takes place within Orthopaedic Spinal Clinics where staff consist of Physiotherapists and Medical Officers. The majority of patients are not likely to benefit from surgery. Instead, patients are offered reassurance regarding their spinal condition and advice to promote non-surgical strategies such as a graded activity plan. There is evidence linking reassurance to patient satisfaction and condition management however limited evidence that Physiotherapists and medical officers can equally reassure patents following an assessment in Orthopaedic spinal clinics. The primary aim of this pilot study is to evaluate the level of reassurance reported by patients via the Consultation Based Reassurance questionnaire (CRQ) following exposure to either the Physiotherapist or medical officer model of care in an Orthopaedic Spinal Clinic. Secondary outcomes of interest include pain, functional limitations and confidence managing pain symptoms. Outcomes are assessed at baseline, 1 day following clinic and 3 months following clinic.

  • Post-discharge nutrition care post hip fracture: a feasibility study

    Malnutrition is common among hip fracture patients and results in adverse outcomes. The primary aim of this study is to assess the feasibility of intervention delivery and evaluation design in preparation for a larger trial to determine whether providing high energy, high protein meals to older patients following hospitalisation for hip fracture improves patient reported measures and health related outcomes. Primary outcomes relate to feasibility of the intervention and evaluation design. Secondary outcomes include quality of life, patient-reported experience measures, nutritional, functional and health outcomes, and likelihood of cost-effectiveness. This study has potential to improve quality of life and other health outcomes post hospitalisation for hip fracture. If the intervention is shown to be feasible to deliver and evaluate, further research will assess clinical and cost effectiveness.

  • Oral safety and efficacy of eucalypt sap resin in the management of recurrent vulvovaginal candidiasis

    The purpose of this study is to assess safety of internal eucalypt sap resin consumption and also to explore if a low dose taken over a period of six months may be able to decrease vulvo-vaginal candidiasis episodes and concurrent gastrointestinal symptoms in women with recurrent vulvo-vaginal candidiasis (RVVC) and gastrointestinal symptoms of microbial imbalance. With the prevalence of RVVC and lack of safe long-term treatments for managing the symptoms of candida overgrowth (both gastrointestinal and vaginal), we are investigating this ingredient for potential in the management of RVVC alongside long-term safety.

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