ANZCTR search results

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

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32928 results sorted by trial registration date.
  • Can a mobile app support recovery after hip or knee replacement? A feasibility study of patient engagement and usability

    This study will assess the feasibility of using a digital rehabilitation support platform to assist recovery in patients undergoing total hip replacement (THR) or total knee replacement (TKR). Participants will receive usual physiotherapy care and access to a mobile application that provides exercise programs, education, and reminders to support rehabilitation before and after surgery. The study will evaluate whether the platform is acceptable and usable for patients, and whether study processes such as recruitment, retention, and data collection are practical to support a future larger study. Participants will complete online surveys before surgery and at 4 and 12 weeks after surgery, with a subset invited to take part in an optional interview to provide feedback on their experience. Findings from this study will help inform the design of a future larger trial and explore whether digital rehabilitation support may improve access to physiotherapy, particularly in regional and rural settings.

  • Cystoscopic Local Endoscopic Application of RADA16 (PuraStat®) for refractory haematuria secondary to Radiation Cystitis) (CLEAR-RC)

    Established treatments for radiation cystitis (diathermy, hyperbaric oxygen and intravesical instillations) have high failure rates and complication rates. RADA 16 is approved for and has been used extensively for haemostasis in surgery. Protocols for its use in the treatment for radiation proctitis are also well established. For radiation cystitis there is a single case report and a case series (of which the CPI is the primary author) for UK patients. These have both demonstrated good outcomes for patients who otherwise are facing either palliation or complex, salvage surgery which many of these patients may not be fit to undergo. More research is needed to establish if this is a treatment that would be beneficial for a cohort of patients with refractory haematuria from radiation cystitis, a debilitating condition often requiring substantial use of hospital resources.

  • Does self-guided reminiscence lead to greater reductions in depressive mood compared to a control condition?

    This study aims to examine whether a brief, self-guided writing activity focused on personal memories can improve mood in older adults. Many older adults experience low mood that does not meet criteria for clinical depression but still affects their wellbeing, and there is a need for simple, accessible strategies that can help. In this study, participants will be randomly assigned to either complete a short, structured reminiscence writing task or to a comparison (control) condition. The writing task will guide participants to reflect on meaningful past experiences, with a focus on moments of personal strength, coping, and achievement. We expect that participants who complete the reminiscence writing task will show greater improvements in mood compared to those in the control group. We also expect that these improvements will be partly explained by an increased sense of mastery (i.e., feeling more in control of one’s life and able to handle challenges). The findings may help identify a simple, low-cost, and private intervention that could support emotional wellbeing in older adults.

  • The CONTINUUM project: Coordination of Long-Term Rehabilitation for Indigenous Patients to Improve Quality of Life and Outcomes

    This randomised, open-label, intervention study aims to implement culturally appropriate coordination for personalised rehabilitation programs over and above the usual pathways of care for Aboriginal and Torres Strait Islander people returning to the community following a heart, stroke or diabetes-related hospitalisation at the Royal Adelaide Hospital. Aboriginal Australians face an epidemic of chronic disease and a significant gap in total disease burden compared to non-Aboriginal Australians. Rehabilitation is key to managing chronic diseases, reducing mortality, unnecessary re-hospitalisations and healthcare costs. The study aims to recruit 300 Aboriginal or Torres Strait Islander adults who are hospitalised with chronic disease and referred to specialised rehabilitation. Eligible participants will be randomised to receive 12-months of coordinated care for their individualised rehabilitation plan (intervention) or usual care (control). The study will determine whether coordinated care for rehabilitation plans improve the receipt of evidence-based healthcare and quality of life for Aboriginal people with chronic disease.

  • Psilocybin-Assisted Concussion Therapy for Persisting Post-Concussion Symptoms

    A double-blind randomised controlled trial in persistent post-concussion symptoms (PPCS). The treatment involves psychotherapy sessions before and after one dose of a psychedelic drug called psilocybin, and a daily self-directed integration program for the 2-week period after the psychedelic session. In addition, the research study also involves several screening procedures, blood collection, neuroimaging and completion of questionnaires and interviews.

  • Trial of Electronic Patient Reported Outcome Measures (ePROMs) for the collection of primary endpoints in a trial of lignocaine for the prevention of post-operative pain in breast cancer surgery.

    Trial of Electronic Patient Reported Outcome Measures (ePROMs) for the collection of primary endpoints in a trial of lignocaine for the prevention of post-operative pain in breast cancer surgery. Brief description of the study purpose The LOLIPOP Trial ePROMs substudy aims to test how reliable and acceptable electronic patient reported outcome measures (ePROMs) are for collecting pain information from participants in the LOLIPOP trial. The study compares pain data collected electronically with pain data collected by telephone follow up and explores which follow up method participants prefer for future research. Who is it for? You may be eligible for this study if you are in Australia who have already consented to take part in the LOLIPOP trial and agree to opt in to this substudy. Study details Participants will be invited to complete pain questionnaires electronically using a secure system called ePROMs that sends reminders by email and/or SMS around 12 months after their surgery. All participants will also receive a standard follow up phone call from a research coordinator to collect the same pain information, allowing comparison between electronic and phone based data collection. It is hoped that the findings will help provide further information on which form of follow up participants would most prefer for future research.

  • Preoperative Intervention & Management for Excess weight (PRIME): A multi-site, randomised controlled trial to evaluate the safety and acceptability of pre-surgery dietitian support versus usual care for patients with excess weight scheduled for colorectal cancer surgery

    This study aims to compare usual care with a remotely delivered, dietitian led very low calorie diet (VLCD) program to assess whether pre surgery weight loss is safe and acceptable for patients with excess weight awaiting colorectal cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 or over, with a body mass index (BMI) of 28kg/m² or above, and scheduled for elective colorectal cancer surgery. Study details All eligible participants will take part in a multicentre, two arm randomised controlled trial conducted across Metro South Health facilities. Participants will be randomly assigned to one of two groups: usual care (no weight loss intervention before surgery) or participation in a remotely delivered, dietitian led very low calorie diet clinic prior to surgery. Participants allocated to the intervention group will follow an individualised VLCD at home, supported by weekly dietitian appointments delivered via telehealth (video or phone). The diet uses meal replacement products alongside selected vegetables and fluids and is tailored to individual needs. Dietitians will provide education, monitor adherence, and offer ongoing support until surgery, with additional contact by SMS or email if required. Participants in the usual care group will proceed to surgery without a pre operative weight loss program. After completion of the intervention, participants will be assessed for adverse events, physical function and surgical outcomes. It is hoped this research will inform clinical practice by clarifying whether a remotely delivered VLCD program is a safe and acceptable pre operative approach for people with excess weight undergoing colorectal cancer surgery, helping guide future care decisions and improve surgical outcomes.

  • Evaluating the impact of a nurse-led clinic model of care on the symptom management of women prescribed adjuvant endocrine therapy for early breast cancer

    This study aims to evaluate whether a nurse-led clinic using electronic symptom monitoring can improve support for women starting adjuvant endocrine therapy after early breast cancer treatment. Who is it for? This study is for women aged 18 years or older diagnosed with primary early-stage hormone receptor–positive breast cancer, prescribed and consenting to commence adjuvant endocrine therapy (AET) and able to read and understand English. Study details Participants will complete regular online symptom assessments during the first 12 weeks of treatment which will be reviewed by cancer care nurse specialists. All participants will be included in the study if they meet the eligibility criteria and consent. There are no tests required for the study however depending on specialist nurse review of reported symptoms and side effects participants may be referred for tests as part of their disease management. It is hoped this nurse-led clinic using electronic symptom monitoring can improve symptom management and treatment adherence while reducing the need for routine oncology follow-up visits.

  • GAMES 3: Glibenclamide Advantage in Malignant Edema and Stroke 3

    A stroke occurs when a clot blocks one of the blood vessels to the brain. This causes poor blood supply and lack of oxygen to the brain tissue. If blood supply is not restored to the brain there is permanent brain damage. Endovascular thrombectomy is an effective treatment to restore blood supply to the brain and reduce disability. However, patients with extensive brain injury due to the stroke can develop brain swelling after restoration of blood flow that increases pressure inside the skull and can cause drowsiness, increased disability and potentially death. This swelling tends to occur over the first 3 days. The aim of this study is to test whether a medication called glibenclamide can reduce this brain swelling and improve outcome after stroke.

  • Phase II Trial of Deflexifol for Refractory or Recurrent Paediatric Central Nervous System (CNS) Tumours

    This is a multicentre Phase II clinical trial to establish if Deflexifol is safe and effective in children, adolescents and young adults with recurrent or refractory brain tumours. Who is it for? Participants may be eligible for this study if they are older than 12 months and up to 21 years old and have a recurrent or refractory ependymoma. Study details Participants will receive Deflexifol every 2 weeks for up to approximately one year, if there is ongoing clinical benefit. Deflexifol will be administered via an injection over 3-5 minutes (bolus), followed by a continuous intravenous infusion over 46 hours. Safety will be assessed throughout the course of treatment and during follow up visits. Participants will have physical examinations, blood tests, urine tests, echocardiogram, electrocardiogram (ECG) and MRI scans. This study will test the safety and effectiveness of this drug in children and adolescents in cases where treatment options are limited.

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