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.
  • Implementation of Safewards to manage the use of restrictive practices in residential aged care

    Safewards is a model that was developed in the United Kingdom for use in mental health inpatient services. The model is based on training staff, and giving staff the resources, to implement 10 psycho-social interventions that allow staff to reduce resident distress, agitation and anger. By doing so, the interventions reduce escalation of conflict between staff and residents, and in reducing conflict, there is a reduction in the use of restrictive practices, such as the use of physical restraint. The study we are undertaking is testing if the Safewards model is effective in residential aged care.

  • Active Start Active Future: a randomised control trial of an early behaviour-change intervention targeting physical activity levels in young children with cerebral palsy

    Children with cerebral palsy (CP) participate less in physical activity and have high levels of sedentary behaviour compared to children without CP. In this research we will conduct a mixed methods randomised controlled trial called Active Start Active Future with families who want to support their child’s physical activity participation and consider their own physical activity. We are aiming to determine whether Active Start Active Future is effective in changing the amount of physical activity, physical activity participation and reduce sedentary time for the child at home, in the community, preschools and schools. We will ask parents about their understanding and beliefs around physical activity and sedentary behaviour for their child with CP, explore the parents’ own physical activity behaviours, and explore ways they can support their child be more active. Our aim is to recruit 40 children aged 3-7 years with CP in Gross Motor Function Classification System (GMFCS) levels II-V inclusive of children who need gait aids for mobility or do not walk. We will conduct a physical activity behaviour-change intervention once a week, for 8 weeks face-to-face (with telehealth opportunities if requested). Our trial is innovative because it intervenes earlier in the development of sedentary behaviour and will be one of the first studies to include children who cannot walk independently. The intervention is grounded in evidence-based theories of health behaviour change, individualised for each family, and will be delivered by a paediatric physiotherapist or occupational therapist. Anticipated benefits include gaining a greater understanding of physical activity participation in young children with CP and mechanisms to help change behaviours.

  • Effectiveness Of Psychedelic Therapy for Post Traumatic Stress Disorder (PTSD)

    We intend to measure the effectiveness of psychedelic assisted medicines (methylene dioxy methamphetamine - MDMA) when combined with talking therapy; for the treatment of Post Traumatic Stress Disorder in real world patient groups We will test how effective MDMA is for PTSD and treat patients who have had limited benefits with existing treatments for these hard to treat conditions.

  • Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)

    We intend to measure the effectiveness of psilocybin when combined with talking therapy for the treatment of Treatment Resistant Depression (TRD) in real world patient groups We will test how effective psilocybin is for TRD and treat patients who have had limited benefit from existing treatments for these hard to treat conditions

  • Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion (The Australasian Malignant PLeural Effusion (AMPLE)-5 Trial)

    Patients with malignant pleural effusion (MPE) and their carers report high rates of unmet supportive care needs. Multi-disciplinary interventions, specifically addressing nutrition, targeted physical activity counselling, and psychological support are recommended by international guidelines for advanced cancer. This study aims to find out if integrated supportive care involving nutritional, physical activity, and psychological well-being care plans can improve participation in daily physical activity in people with MPE. The study also aims to find out if this multidisciplinary counselling can improve quality of life, malnutrition risk, psychological well-being, and symptoms. Who is it for? You may be eligible for this study if you are aged 19 years or older, and have been diagnosed with a malignant pleural effusion and you are willing to comply with the research procedures. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. The first group will take part in the integrated supportive care program. This program lasts for 12-weeks and includes counselling sessions in week 1, week 4, and week 8. Each counselling session will take about one hour to complete. This includes about 20 minutes each for dietetics, physical activity, and psychological well-being. The second group will will receive standard medical care as per attending physician, with referral to supportive services if indicated. This group will be called by a member of the research team at week 4 and week 8 to discuss any adverse events that have happened to you. Both groups will receive standard medical care from their treating physician throughout the study, including access to support services.

  • A Phase IIb trial assessing a Chinese Medicine for Dizziness and Vertigo.

    Dizziness is a common but poorly defined condition in people, particularly those over 50 years old. In people 50 years or older, the self-reported prevalence of dizziness and vertigo is over 34 percent. The impact that dizziness and vertigo can have on people over 50 is very relevant as it’s linked with conditions such as isolation, depression, reduced self-autonomy and self-control. It can hamper the social, functional, and psychological well-being of those experiencing dizziness and vertigo which in turn, can reduce quality of life. The trial aims to examine the efficacy and safety of the Chinese formula for preventing and treating dizziness.

  • In vitro study of the effects of sugammadex on the measurement of serum concentrations of progesterone in premenopausal women – an assay validation study

    This research project is looking at whether sugammadex interacts with progesterone assay testing, and therefore affects the reliability of progesterone concentration measurements. An interaction at 104micromol/L is reported by the manufacturer of Sugammadex. This research project will look at the accuracy of progesterone assay testing in the presence of various sugammadex concentrations.. This study is important to assess the reliability of data that utilising progesterone assay testing when using sugammadex.

  • Wait a Minute or More: A pragmatic stepped wedge cluster randomised implementation trial assessing a quality improvement program to increase delayed cord clamping for preterm infants.

    Delayed umbilical cord clamping after 60 seconds improves outcomes for preterm infants born before 37 weeks. However, delayed clamping is neither reliably recorded nor routinely implemented across Australian hospitals. This study will investigate whether funded basic, accurate data collection and sharing between sites together with a funded, locally adapted quality improvement program increases the average number of seconds before cord clamping (NSCC) by 30 seconds, compared to funded basic, accurate data collection and sharing alone.

  • Restoration of gut microbiota in Persistent Critical illness using Faecal Microbiota Transplantation (The ROCIT-FMT Trial): a pilot phase I/II trial

    In this prospective, 2 stage interventional pilot study we aim to evaluate the safety and feasibility of FMT as a therapeutic intervention for dysbiosis associated with persistent critical illness, in patients who have been admitted to the intensive care unit (ICU) at a tertiary hospital in Western Australia. Subsequent preliminary evaluations of the efficacy of FMT at restoration of microbial diversity, richness and evenness in the recipient together with important clinical outcomes including the incidence of infection and burden of MDRO colonisation will be secondary endpoints.

  • A Phase 1b, Single-centre, Open-label Study to Evaluate Food Effect and the Drug-Drug Interaction of Omeprazole, Itraconazole and Rifampin on Tinlarebant in Healthy Adult Subjects

    This is an open-label study to evaluate the effect of food and drug-drug interaction with tinlarebant. This study will assess the effect of omeprazole, itraconazole,rifampin and food on the pharmacokinetics of tinlarebant.

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