ANZCTR search results

The aim is to assess at what timepoints any relevant MRI changes are seen with upadacitinib use; which aspects of rheumatoid involvement respond earliest; and if this precedes the timepoints when other clinical RA outcome measures change. Clinical response to treatment will involve assessing response to treatment on MRI of the participant’s most affected hand/wrist (as determined by Investigator assessment by examination at screening). This trial will observe improvements in MRI tenosynovitis, synovitis and osteitis, and evaluate the time to improvement/resolution of these MRI features, as well as clinical outcome measures such as inflammatory markers and joint count assessments. In addition, participant reported outcomes (PROs) will be completed to assess the overall disease activity levels as reported by the participant. The PROs chosen include the conventional PROs EQ-5D, SF-36, FACIT-F and PtGA as these are well-established PROs that have demonstrated validity and reliability in assessing disease state, as well as a specific upper limb function PRO, the DASH. The DASH, which was developed by the Institute for Work & Health4, specifically assesses hand function and is therefore relevant to the objectives of the study. This trial is novel in nature as it looks are earlier MRI timepoints than what has been completed in earlier clinical trials and also compares the MRI findings to PRO data captured at the same timepoint, which has also not been completed in earlier trials.

This is an open labeled pilot study of 10 participants that will be treated with medicinal cannabis (THC: CBD 10:15 oil) in reducing tics-related symptoms in adolescents aged 12 - 18 years with Tourette Syndrome. Eligible participants will receive THC:CBD 10:15 oil. This pilot study will assess the feasibility of conducting a large scale, study of the administration of MC (THC:CBD 10:15 oil) in adolescents with TS. This pilot study will also assess the safety and tolerance of the administration of THC:CBD 10:15 oil in adolescents with TS. Clinician and parent symptom ratings will be compared across the conditions to explore for a signal of efficacy.

The RESPECT trial aims to determine the clinical impact of a conservative fluid protocol (CFP), that is minimizing fluid administered and maximizing urine produced, compared to usual care in patients admitted to the intensive care unit and have an acute impairment in their kidney function. The hypothesis is that a CFP will result is less severe derangement in kidney function and will result in better patient outcomes, such as less need for dialysis. This will be done by randomizing patients to one of the two groups: CFP and usual care. The expected outcomes are divided into feasibility and clinical outcomes. The main feasibility outcome will be a difference in fluid administered after three days between the two groups. This is to ensure that CFP differs sufficiently from usual care. The main clinical outcomes is a reduction in blood levels of creatinine, which is a marker of the severity of kidney injury.

There is considerable evidence that corrections officers are at higher risk of mental health problems, largely arising from traumatic events and ongoing stressors in prisons. This program aims to trial an innovative Resilience Training program that builds on a program developed by the World Health Organization to teach awareness about identifying stress, stress reduction strategies, problem management, and maintaining productive and social activities. The Resilience Program will also provide participants with an app to download on their phones that will provide them with exercises to practice stress reduction strategies. The trial will randomise 600 NSW Corrective Services personnel to either the Resilience Program or Repeated Assessment conditions. The Resilience Program will provide 2 x 2-hour sessions administered by clinical psychologists one month apart, delivered in groups of 10-15 people. Participants will be assessed for psychological distress and help-seeking at baseline, 2-months, and 6-months, with the 6-month assessment being the primary outcome timepoint. The trial will also for sickness leave from Department of Corrective Service work records.

Our landmark trial published in The Lancet in 2011 demonstrated that facilitated implementation of nurse-initiated protocols to manage fever, hyperglycaemia (sugar) and swallowing difficulties (FeSS Protocols) resulted in significantly reduced 90-day death and dependency for stroke patients. However, ten years on, a significant gap remains in translation of the FeSS Protocols into standard stroke care across Australia, particularly notable in rural and remote settings. A program of systematic Australia-wide implementation is urgently needed. To date, systematic implementation of the FeSS Protocols has not occurred in New Zealand. Therefore, the specific aims of this study are: 1) To determine the effectiveness of a large scale intervention with varying intensities of external remote facilitation in enhancing simultaneous multi-site delivery to promote multi-national uptake of the FeSS Protocols to improve management of fever, hyperglycaemia and swallowing difficulties in the first 72 hours of stroke unit/stroke service admission. Specifically, we will compare the effectiveness of: a) low intensity versus high intensity external remote facilitation. b) low intensity versus no external remote facilitation. c) high intensity versus no external remote facilitation. 2) To determine whether post-intervention implementation changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between metropolitan and rural/remote hospitals. 3) To determine whether post-intervention changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between stroke units and stroke services. 4) To describe the potential cost-effectiveness of the different facilitation methods (economic evaluation). 5) To identify clinicians’ views regarding factors that influence uptake of the FeSS Protocols in metropolitan and rural/remote hospitals (process evaluation). A three-arm cluster randomised controlled trial, process evaluation and economic evaluation (sub-study) will be undertaken. Hospitals will be randomised to one of two intervention (low and high intensity external remote facilitation) or control (no facilitation) groups. Australian and new Zealand hospitals with a pre-existing stroke unit/service will be eligible. Multi-national implementation of the proven FeSS Protocols into innovative policy and practice will result in better outcomes for survivors of stroke, particularly in rural and remote Australian and New Zealand settings.

This is an observational, longitudinal registry of paediatric, adolescent, young adult (AYA) and rare adult tumour patients from a select group of tumour streams treated with radiotherapy. The registry is designed to describe the patterns of care for patients receiving photon versus proton radiation treatment. Who is it for? You may be eligible for this study if you are receiving radiotherapy for cancers of the following types: Base of Skull Meningioma, Chordoma, Chondrosarcoma, Tumour of the vertebral column or bony pelvis, Chordoma, Chondrosarcoma, Osteosarcoma, Ewing’s sarcoma of pelvis, Adenoid cystic carcinoma of the salivary or lacrimal gland, CNS, Medulloblastoma, Ependymoma, Glioma, Astrocytoma, Orbit, including retinoblastoma, Retinoblastoma, Axial skeleton or close proximity to axial skeleton, including bone or soft tissue sarcoma Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma of axial skeleton, Craniopharyngioma, Intracranial germ cell tumour, Neuroblastoma, or Nephroblastoma Study details There are no clinical interventions required for participants enrolled onto the registry. All enrolled participants will receive treatment, and follow-up care as pre-determined by their treating clinician, in accordance with the standard of care at the treating institution. All treatment interventions that participants receive, and all outcomes will be recorded on the registry database from the patient medical record. It is hoped that the development of this registry will assist in describing the long-term effects and disease control outcomes for patients having radiotherapy as part of their cancer treatment.

The purpose of this study is to determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life in men with prostate cancer undergoing androgen deprivation therapy (ADT). The study will also evaluate whether the intervention is cost-effective, acceptable, appropriate, and feasible compared to usual care. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with prostate cancer, are commencing or within 3 months of commencement of ADT, and are expected to continue ADT for a minimum of 12 months. Study details Participants will be randomised (i.e. allocated by chance) to receive the PCEssentials intervention, or usual care. The PCEssentials intervention will involve five 1-hour psychoeducation sessions delivered via telehealth by a trained prostate cancer specialist nurse. These sessions will occur weekly for four weeks with a booster session at 3 months after recruitment, and will involve one-to-one psychological support, treatment education, tailored strategies to help manage distress, decision making and self-management. Participants in the intervention group will also be provided with a home-based exercise activity program tailored to their need and ability. Participants allocated to usual care will receive their standard management that is minimally enhanced with a package of evidence-based resources containing patient education materials about the use of ADT to treat prostate cancer; and advice about referral to support services. All participants will answer a number of questionnaires at the time of recruitment, and at 3, 6, and 12 months after recruitment to assess for changes to quality of life, self-efficacy, psychological distress, sleep, fatigue, and physical activity levels. Interviews will also be conducted to assess for acceptability of the intervention, and a health service use diary will be used to perform cost-effectiveness analysis. It is hoped that this research will demonstrate that the PCEssentials intervention is feasible, acceptable, and effective in improving quality of life, self-efficacy, and sleep, and reducing distress and fatigue in individuals with prostate cancer being treated with ADT.

This quantitative project will involve a cross-sectional study which will measure self-stigma (SS) prevalence and severity among the Western Australian youth (16 -24 years) mental health population. It will also profile SS by exploring its relationship with several measures of demographic, mental and physical health, behaviours, and wellbeing. A minimum of 436 youth with a mental illness are required for the cross-sectional survey. It is hypothesised that moderate to severe internalised stigma will affect approximately 25% of youth with a mental illness. Additionally, it is hypothesised that those with lower SS severity will present as relatively more recovered, demonstrate stronger self-orientation towards empowerment and have better quality of life.

COVID-19 has multiple facets including cytokine storm, thromboembolism, renal impairment, and mucinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious effects, in which patients succumb to acute respiratory distress syndrome (ARDS). The development of mucinous sputum plugs in individuals infected with SARS-CoV-2 in addition to cytokine storm is of great clinical importance, correlating with negative outcome. Bromelain and Acetylcysteine (BromAc) is a potent mucolytic applied in highly mucinous tumours of the appendix. Previous research has shown that BromAc cleaves the glycoproteins of the SARS-CoV-2 virus (antiviral), is a mucolytic, dissolving COVID-19 and other respiratory sputum in clinically relevant times, and down regulates cytokines and chemokines in sputum from ventilated COVID-19 patients. The investigators now seek to examine the safety of nebulised BromAc in healthy volunteers to assess any symptoms or side effects prior to progressing towards a potential treatment option in patients with severe COVID-19.

This is a proof of concept study with the purpose of examining the anti-tumour immune response after local irreversible electroporation (IRE) in patients with prostate cancer. Who is it for? You may be eligible for this study if you are male, aged 18 years or over, have prostate cancer, and scheduled for either IRE or radical prostatectomy. Study details There will be two groups of participants: patients scheduled for IRE, and patients scheduled for radical prostatectomy. Both groups of participants will undergo their scheduled treatment as usual. In addition, both groups will have blood samples collected before treatment, and on days 3, 14 and 30 after treatment. It is hoped that this research will improve understanding of systemic anti-tumour immune response after IRE, and thus offer insight for future cancer treatment strategies.