ANZCTR search results

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

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31027 results sorted by trial registration date.
  • Deferral of active treatment using focal irreversible electroporation for men with localised prostate cancer

    Prostate cancer continues to be one of the most commonly diagnosed cancer in men and a leading cause of cancer related death worldwide. When prostate cancer is in its early stages, meaning that it has not spread outside the prostate gland, surgical excision of the prostate and radiation to the pelvis have been shown to be effective treatments. However, these treatments frequently leave men with side effects. The main two being erectile dysfunction and urinary incontinence. Over the last decade, new treatment strategies have been aimed at delaying or mitigating the need for prostate excision or radiation therapy to save men from these side effects. Irreversible electroporation (IRE) is a new form of technology which uses electrical pulses to kill cancer cells within the prostate. These electrical pulses are applied through metal probes placed strategically around the cancer in the prostate. The heat generated is kept below “thermal” levels to ensure important structures that surround the prostate (nerves and blood vessels) are not damaged by the treatment. For the moment, studies on IRE have been limited by numbers and short term follow up data. This study will follow and analyse men undergoing IRE. It will include men who have newly diagnosed localised prostate cancer and also men who have localised recurrent prostate cancer after radiotherapy. We aim to assess cancer outcomes through a series of imaging (MRI and PSMA PET/CT), blood tests and biopsies (TP biopsy). Additionally, we aim to analyse functional outcomes through questionnaires. Our study will add the growing evidence of men undergoing IRE around the world. Who is it for? You may be eligible to participate if you are aged 18 years or older, and have been diagnosed with prostate cancer - either newly diagnosed localised prostate cancer, or localised recurrent prostate cancer after radiotherapy. Study details: All participants will undergo IRE surgery, conducted under general anaesthesia. The surgery will take around 30-60mins. Follow up will consist of a 3, 6 and 12 months review. This will be done in clinic with the treating Urologist. At 3 months, participants will be assessed with a serum PSA, and completed EPIC-26 Quality of Life questionnaire. At 6 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire and prostate MRI. At 12 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire, PSMA PET and prostate biopsy. It is hoped that this research will improve understanding of IRE treatment, and lead to better treatment for men with prostate cancer.

  • Clinical evaluation of the Wandi Nerida Residential care facility.

    The proposed study will comprise a 2-armed, 2-site, data-analytic blind clinical trial to determine the clinical effectiveness of the Wandi Nerida program. The data management site will be at the WSU Macarthur Clinical School. The recruitment and treatment sites will be at the Wandi Nerida program and the Royal Brisbane Hospital Day program. The project will be informed by a co-design and Participatory Action Research (PAR) approach. Over a 24-month period we have been advised to anticipate 120 Wandi Nerida participant and 46 Day Program participant separations. Continued recruitment for an additional 6 months would ensure a minimum of 60 participants per group. This estimate this will allow for a mean difference medium effect size of .5 for eating disorder symptoms severity or other continuous outcomes using Cohen’s table. The number who do not engage with and/or do not complete (leave within 4 weeks of treatment) at the Wandi Nerida program is unknown at this stage.The data set for the Clinical Evaluation will include but is not limited to measures on: eating disorder diagnosis prior to residential treatment; body mass index; psychopathology; ability to complete daily activities; related mental health and wellbeing scores (comorbidities); and QALY estimates. The research will extend upon the minimum data set developed by the Federal Technical Advisory Group (TAG) to also include measures that assess outcomes related to (1) the unique aspects of the B-FREEDT model of care through qualitative exploration, (2) the testing of key indicators for measuring change, (3) changes in concurrent and ongoing healthcare utilisation, (4) stakeholders other than the clients themselves and extending to family members and clinicians inside and external to Wandi Nerida, and (4) the monitoring of clinical outcomes of clients and their families over six months from start of treatment. Notably only the data pertaining to primary outcomes will be collected a the control site.

  • Effect of ADVice Versus exercISE via telehealth on shoulder pain and disability in adults with rotator cuff tendinopathy: a randomised controlled trial (the ADVISE trial)

    Rotator cuff tendinopathy is a common type of shoulder pain that can severely impact work and general function. It is not currently known whether exercise and education which is recommended care can be delivered via telehealth for this condition. Telehealth has huge advantages including convenience for the patient, ability to reach people in remote regions, and potential healthcare cost savings. The aim of this trial is to compare active control (online education leaflet only ARM 1) with exercise and education delivered via one session (ARM 2) or six sessions (ARM 3). We hypothesis that pain and function outcome will be superior in ARM 2 and 3 versus ARM 1 at 12 weeks. The primary outcome measure will be the Shoulder Pain and Disability Index (SPADI) at 3 months (enough to see an effect of the intervention on clinical outcomes) post randomization, a well validated, reliable and region-specific measure of shoulder pain and disability. This parallel group three-arm trial will randomise 333 people into the three trials arms. The education and exercise in arms 2 and 3 will be delivered via telehealth (Zoom) and in groups (3 participants to 1 physiotherapist). In Arm 3 follow up will occur at week 2, 4, 6, 9 and 12. Outcomes including pain, function, psychological status, sleep, quality of life, global rating of change, worse pain over the last 7-days, working alliance, adherence, health care use, exercise adherence, productivity, adverse events, and telehealth acceptability will be assessed at baseline, 6 weeks and 3 and 12 months.

  • Transforming treatments for schizophrenia: Virtual reality, brain stimulation and social cognition.

    Theory of mind is a social cognitive domain impaired in people with schizophrenia and has significant impact on functioning including difficulty in social interactions, poor interpersonal relationships and reduced conflict resolution ability. Current interventions are highly intensive, require significant resources and have only modest effects on functional outcomes and new innovative treatments are needed. Virtual reality (VR) and transcranial alternating current stimulation (tACS) will be combined to engage the rTPJ while undergoing theory of mind tasks and use electrical currents to further engage and enhance abnormal neural firing patterns simultaneously. Forty-six participants (23 schizophrenia, 23 controls) will attend 3 research sessions. One comprehensive baseline assessment completing a short interview and cognitive and social cognitive tasks as well as two VR social cognition tasks with simultaneous tACS. At the end of session three participants will have received one sham tACS and one active tACS session simultaneously with VR. We are investigating the effects of combining tACS with VR in single sessions on brain activity to inform future research and potential treatment. Participants will also complete short questionnaires regarding their experience.

  • CONFIRM: The Diagnostic Utility of Prostate Specific Membrane Antigen Positron Emission Tomography/Computed tomography (PSMA PET/CT) in Men with Newly Diagnosed Low-Grade Prostate Cancer with High-Risk Features, on Active Surveillance (regular testing for any changes in the cancer that could lead to harm), Awaiting Confirmatory Biopsy

    Who is it for? You may be eligible to join this study if you are aged 18 years or above, male, and have a new diagnosis of prostate cancer that is being managed through active surveillance. Study details All participants in this study will undergo the usual monitoring processes of mpMRI and confirmatory biopsy. In addition, all participants will undergo one PSMA PET scan at the time of their repeat mpMRI, and, if applicable, one PSMA-targeted biopsy at time of their confirmatory biopsy. The repeat mpMRI and PSMA PET/CT will occur at Epworth Medical Imaging, Freemasons. The results of the scans and biopsies will be used by a panel of experts to make recommendations as to whether the participant should remain on active surveillance for their prostate cancer, or receive active treatment. It is hoped that this research will improve the accuracy of prostate cancer monitoring, and lead to better outcomes for patients who are in active surveillance.

  • Gastroparesis symptoms and its treatment using low-viscosity soluble dietary fibres

    The principal aim of this clinical study was to determine the short-term blood-glucose control and tolerability of Partially-hydrolysed guar gum (PHGG) and Gum Arabic in mild-to-moderate symptom gastroparesis patients. There were four interventions in total, the test fibres PHGG and Gum Arabic, the positive control Psyllium Husk and the negative control Water. The study hypothesizes that the 'low-viscosity' test fibres PHGG and Gum Arabic provide blood glucose regulation / control comparable to the positive control, Psyllium Husk, while causing fewer severe symptoms comparable to the negative control, Water.

  • Seaweed extract, Fucoidan, as a supplement to support the development of muscle strength and function in sedentary individuals

    Edible seaweeds (macroalgae) have the potential to provide a rich and sustainable source of macronutrients and micronutrients to the human diet. The recent surge of interest in seaweed is fueled by attention on the bioactive components of seaweed, which have potential applications in the food and nutraceutical industries, with impetus toward the reducing cholesterol and improving blood sugar levels. One candidate bioactive compound of interest is the polysaccharide, Fucoidan. Fucoidans are found in brown seaweeds and the health benefits of Fucoidans have been demonstrated in both human and animal studies where the multiple effects include anti-inflammatory, anti-oxidant, anti-tumour, and immune-modulating properties. Our research group in collaboration with industry leading Fucoidan producers (Marinova Pty Ltd) have shown in a pre-clinical study in mice that in the absence of exercise, a novel Fucoidan blend increased muscle mass. While the animal study evidence does exist for Fucoidan influencing muscle health, more human evidence (including mechanistic evidence) is needed to evaluate both the nutritional benefit conferred and the efficacy of Fucoidan on muscle health. Therefore, the aim of this pilot clinical trial is to evaluate the effect of oral supplementation of a Fucoidan blend on muscle health and lean body mass in healthy human subjects not participating in any form of exercise. We hypothesize that fucoidan could be a supplement that increases muscle strength without a need for exercise. Here we propose a study designed to establish whether a novel fucoidan blend can improve muscle and body health in sedentary participants.

  • Safety of anticoagulation in elective colonoscopy

    The aim of this study is to investigate if patients can safely continue their blood thinner medication for small polypectomies without any procedure related complications.

  • EndoSMS: A text message supportive program for individuals with endometriosis

    With 1 in 9 Australians of childbearing age living with endometriosis, this chronic condition is characterised by debilitating physical symptoms which negatively impact on their psychological wellbeing and quality of life. This pilot study will assess the feasibility of a co-designed supportive text message program (EndoSMS) to enhance the psychological wellbeing and quality of life of those with endometriosis. Co-designed text message interventions have been demonstrated to improve health-promoting behaviours and medication adherence in individuals with chronic conditions and are a cost-efficient means of providing health education and support. Text messaging is particularly suited for young to middle-aged people (the majority of those impacted by endometriosis) because mobile phone ownership is high, little effort is required to receive the intervention, and texts can be read/re-read at times that suit users. Informed by psychological and communication theory, this study aims to develop a co-designed bank of text messages focused on providing evidence-based information about endometriosis management, psychological support and tips for self-care and a healthy lifestyle. Following co-designed development of the text message bank, piloting of the EndoSMS intervention will be undertaken with a minimum sample of 120 individuals living with endometriosis.

  • Comparison of tooth decay development around braces bonded to the tooth with two different adhesive materials.

    This within-patient, split-mouth randomised controlled trial aims to determine whether orthodontic bracket bonding with resin-modified glass ionomer cement (RMGIC) to sodium hypochlorite (NaOCl) conditioned enamel will affect the development of white spot lesions (WLSs) compared to brackets bonded with resin composite cement (RC). It is hypothesised that bonding with RMGIC after pre-treatment with NaOCl will reduce the prevalence of WSLs around orthodontic brackets compared to RC.

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