ANZCTR search results

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

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32101 results sorted by trial registration date.
  • The evaluation of a conversation treatment program for people with Parkinson's and their partners.

    The overall aim of this project is to trial a conversation therapy program to improve the quality of conversations between people with Parkinson's and their communication partners. This therapy program was co-designed with people with Parkinson's and their communication partners in the previous phase of this PhD project. Aim1: To evaluate the feasibility and effectiveness of the treatment program through a clinical trial. Aim 2: To evaluate the acceptability, clinical, and social validity of the treatment program, from the perspectives of the people with Parkinson’s and their partners who received the intervention.

  • The effectiveness of the Invisalign Palatal Expander System versus conventional maxillary expander in widening the upper jaw in pre-adolescents

    Invisalign has released a new 3D-printed product (Invisalign Palatal Expander System – IPES) to replace traditional jackscrew-based expander plates in children 6-11 years of age. Instead of relying on a jackscrew-type system to open the jaws, it involves sequential wear through a series of 3D-printed removable plates of progressively greater width. It has recently (early 2024) been launched in global markets, with relevant approval granted from regulatory bodies (TGA & FDA). It has been marketed as equally effective but more comfortable and stress-free to use compared to traditional metal jackscrew-based expansion plates. No external studies have validated these claims.

  • SUBDUE-3: A Phase 0 study of SUB-urothelial DUrvalumab-Zirconium to investigate local and systemic distribution of Durvalumab when injected in the sub-urothelium in adult subjects with muscle invasive bladder cancer or high-risk non-muscle invasive bladder tumours.

    This study aims to investigate the local (bladder wall) and systemic (liver, kidney, lung, bone marrow) distribution of durvalumab with a radioactive isotope when injected in the sub-urothelium for Bladder Cancer (SUBDUE-3) Who is it for? You may be eligible to join this study if you are aged 18 years or above with a diagnosis of muscle invasive bladder cancer or high-risk non-muscle invasive (T1, high grade Ta, carcinoma in-situ) bladder tumours and scheduled for a cystectomy. Study details All participants will receive a single dose of 89Zr-Durvalumab injected to their bladder. Participants will have positron emission tomography (PET) imaging at pre-determined timepoints to visualise the distribution of the drug over time up to 7 days post injection. Blood samples will be taken and any adverse events will be recorded for up to 2 weeks post-cystectomy. It is hoped that SUBDUE-3 will contribute to the further understanding and development of immunotherapy treatments being delivered directly into the wall of the bladder with the aim of achieving bladder preservation in localised bladder cancer. This trial will contribute to the understanding and further development of sub-urothelial immunotherapy as a potential treatment for patients with bladder cancer.

  • Impact of CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) on parenting stress, empowerment and efficacy, and quality of life in caregivers of children with cerebral palsy.

    For parents of children with disabilities, including cerebral palsy (CP), navigating the complex National Disability Insurance Scheme (NDIS) system to develop an evidence-based package of therapies for their child is challenging. Parents tell us that they need to develop advocacy skills and have a greater understanding of what constitutes evidence-based therapies in order to successfully navigate the NDIS system and choose from 182 available therapies and over 1000 service providers. Currently, there are no capacity building programs for parents of children with disabilities that are peer-driven and peer-led. We will iteratively co-develop and test a novel web-based multi-component knowledge platform on EDX called CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills and Support Program) comprising (a) webinars and interactive consumer-led virtual groups for families of newly diagnosed children with CP entering the NDIS systemCP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) will reduce parental stress, increase parental empowerment, self efficacy and family quality of life for parents of young children with cerebral palsy. CP-KASP will be acceptable, feasible and adoptable with high levels of fidelity.

  • Practice Nurses to Augment the Clinical Evaluation and cAre of people at high-risk of Heart Failure (PANACEA-HF) Trial

    When left undiagnosed and untreated, Heart Failure (HF) is a complex, chronic condition associated with poor quality of life, recurrent hospital admissions and premature mortality. Consistent with a recent Strengthening Medicare Taskforce Report, this project is applying the latest point-of-care technology (including an Artificial-Intelligence guided cardiac imaging) to enhance the pivotal role of Primary Health Care Nurses (PHCNs) to cost-effectively detect and then care for people with HF in primary care. In a two-phased approach, >1000 at risk people across 3 urban, regional and rural communities, will be screened for previously undetected HF. Those found to have HF, will then be invited to participate in a trial of standard GP care versus a Practice Nurse-coordinated, multidisciplinary, primary care surveillance and intervention program. We hypothesize that those people assigned to the Practice Nurse coordinated care program will experience better health outcomes than those assigned to receive standard GP care. During minimum two-years follow-up we will compare the health outcomes (including need for hospital care and quality of life) of those exposed to standard care versus the Practice Nurse-led care program.

  • A First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-645 in Healthy Volunteers

    This is a study of an orally administered drug called K-645. This study, which will be conducted in healthy volunteers is a randomized, double-blind,placebo-controlled, single ascending dose study with a primary purpose of assessing the safety and tolerability of single doses of K-645.

  • Implementation of the Choose to Move program in Sydney Australia for people aged 50 and over

    Choose to Move (CTM) is a 3-month program that provides motivation and support to adults aged 50 and over to become more physically active and socially connected. CTM was successfully developed and implemented in Canada and has shown to successfully increase physical activity, mobility and reduce social isolation in older adults. The purpose of this study is to adapt this program to suit adults aged 50 and over living in Sydney who are particularly inactive and not well supported by existing programs. This will be through a process of adaptation (co-design implementation strategies to adapt the program for older adults in Sydney), program implementation and delivery (build organisation capacity, support delivery partners on implementation and deliver 3-month intervention) and evaluation (describe and assess implementation strategies used to achieve ‘best fit’ and to measure CTM program benefits for various health outcomes to the older person). We hypothesise: 1. The Choose to Move program and implementation strategies will require minor adaptations to suit the needs of people aged 50 and over in Sydney. 2. The Choose to Move program will be implemented with fidelity. 3. The Choose to Move program will be acceptable and well attended by people aged 50 and over in Sydney. 4. The Choose to Move program will provide benefits to health outcomes to people aged 50 and over in Sydney.

  • A primary care multi-disciplinary team care approach, including pulmonary rehabilitation, to address uptake and outcomes of comprehensive evidence-based care for Chronic Obstructive Pulmonary Disease (COPD) (MDT-PuRe-Primary Care).

    Multi-disciplinary team care, including access to pulmonary rehabilitation, are key recommendations in the COPD-X guidelines for the management of chronic obstructive pulmonary disease (COPD). However, access to multidisciplinary team care and referral to pulmonary rehabilitation is low in primary care. The aim of this randomised controlled trial is to evaluate the implementation, effectiveness, and cost-effectiveness of two new healthcare strategies (services) to improve the provision of evidence-based management for people with COPD compared with usual GP management of COPD. The two new strategies are to: 1) Upskill registered nurses to provide Multi-Disciplinary Team care planning with the GP for people with COPD (MDT), 2) Provide access to an 8-week PUlmonary REhabilitation program in Primary Care (PuRe Primary Care) delivered by private exercise physiologists or physiotherapists in the community. The study will be conducted in three geographical areas serviced by our partners 1) South West Sydney Local Health District and South West Sydney Primary Health Network, 2) Central and Eastern Sydney Primary Health Network, and 3) The Healthy Communities Foundation Australia. They have all identified that there are unmet health needs for people with COPD in their local area and this is a priority for service innovation and delivery. We anticipate that the implementation of these strategies will improve the management of COPD, improve health outcomes for people with COPD and, in turn, reduce pressures on the hospital system. Our project will focus on the health of the priority populations of those experiencing diseases of ageing, COPD prevalence increases with age, and with people living in rural and remote areas.

  • The effectiveness of an education session prior to elective hip or knee replacement surgery in hospital length of stay at St John of God Berwick Hospital

    This study examines the impact of prehabilitation programs on patients undergoing total knee and hip replacements in Australia, where osteoarthritis is prevalent. Research indicates that these programs, which include supervised exercises and educational sessions, can significantly reduce hospital length of stay and costs, especially for total knee replacement patients. Participants in prehabilitation also report improved functional outcomes, reduced pain, and enhanced muscle strength post-surgery. Despite the positive findings, patients at SJOG Berwick Hospital currently lack access to preoperative education from allied health professionals. The study aims to assess whether implementing an educational session prior to surgery can reduce hospital length of stay for these patients. The hypothesis of this study that attending an education session prior to hip or knee replacement surgery will reduce hopsital lengh of stay post-operatively

  • Comparative analysis of Home-based vs. Laboratory-based High-Intensity Interval Training in Females with Polycystic Ovary Syndrome who are overweight/obese.

    The primary purpose of this study is to compare the effects of home-based High-Intensity Interval Training (HIIT) with laboratory-based HIIT on the health of women with Polycystic Ovary Syndrome (PCOS) who are overweight or obese. The study will examine various health outcomes over a 12-week period, including cardiorespiratory fitness, body composition, and glycaemic control. The hypothesis is that home-based HIIT will be as effective as laboratory-based HIIT in improving these health outcomes. This study aims to provide a more accessible exercise option for women with PCOS, potentially offering a cost-effective and convenient way to manage their condition through home-based training. Participants will undergo baseline testing, engage in the HIIT program, and complete follow-up assessments to evaluate the long-term benefits post 12- week intervention. The study involves researchers from Victoria University, the University of Adelaide, and Monash University, ensuring a comprehensive approach to improving the quality of life for women with PCOS.

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