ANZCTR search results

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

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32212 results sorted by trial registration date.
  • Evaluation of effect of topical application of oral care agent on enamel white spots in healthy adults

    This randomised controlled study will use an assessor-blinded, two-way crossover design to assess the effects of a combination of Tion with 60% CPP-ACP/SnF2 applied under a retainer, and a placebo (no gel) treatment to remineralise/conceal white spots on enamel surfaces using an intra-oral remineralisation model. The Tion gel contains hydrogen peroxide, and the 60% CPP-ACP gel will contain 60% (w/w) CPP-ACP with 1100 ppm fluoride as SnF2. Participants will be randomly allocated to one of the two treatments for each 10 consecutive-day treatment period, during which participants will wear a palatal appliance for 24 hours a day. The participants will rest from the study for one week between each treatment period (washout period). Lay Hypothesis: A combination of a whitening gel TiON and a 60% CPP-ACP/SnF2 gel under a custom retainer can help repair and reduce the appearance of white spots on teeth better than using no treatment (saliva only) control.

  • Assessing the effect of a hybrid spinal fusion surgery with novel techniques on disability and pain in adults with spinal disc injury.

    This longitudinal study will evaluate surgical and patient outcomes following a Hybrid Transforaminal Lumbar Interbody Fusion (TLIF) performed by A/Prof Paul Licina at Brisbane Private Hospital. The Hybrid TLIF integrates the benefits of both open and minimally invasive techniques to enhance surgical precision and recovery. Using advanced technologies — including the CIRQ robotic alignment module, EOS imaging, and the SpineHUB digital education app — the study will capture comprehensive surgical, functional, and patient-reported outcomes. By combining robotic guidance, 3D imaging, and digital engagement, this research aims to provide new insights into optimising spinal fusion surgery and improving patient experience. Findings will help inform best practice and future innovation in spine care.

  • EMVision First Responder Brain Scanner in Aeromedical Retrievals

    This study is workflow assessment and usability study of the EMVision First Responder Brain Scanner in aeromedical workflows. This study collects EMVision brain scans including workflow metrics generated from scan procedures timestamps. This study hypothesises that the proposed EMVision First Responder Brain Scanner aeromedical workflow is suitable for use in an emergency aeromedical stroke response.

  • EMVision First Responder Brain Scanner in the Melbourne Mobile Stroke Unit (Stage 1)

    This trial is the first stage of a staged workflow assessment and data collection study of the EMVision First Responder Brain Scanner for patients suspected of suffering from an acute stroke. This stage of the study is a usability and workflow assessment used qualify the impact of the EMVision First Responder Brain Scanner procedures on the MSU workflow. This study collects EMVision brain scans including workflow metrics generated from scan procedures timestamps. This study hypothesises that the impact of the EMVision First Responder Brain Scanner procedure does not impact the emergency stroke MSU workflow.

  • High dose palliative radiotherapy in patients with metastatic malignancy who cannot or will not have standard of care such as chemotherapy or other drug treatment

    This study is trying to determine whether giving palliative radiation therapy to all known sites of cancer in the body for patients with metastatic cancer can slow down the growth of disease, reduce the rate of new sites developing, improve overall survival and/or improve quality of life. Who is it for? You may be eligible for this study if you are aged 18 years or older and have been diagnosed with a metastatic cancer, including oesophageal, pancreatic, head and neck cancer, cutaneous squamous cell carcinoma, colorectal cancer, bladder cancer, triple-negative breast cancer, non-small cell lung cancer and skin cancer and you are not currently undertaking any oral and/or intravenous therapies for your cancer. Study details Participants who choose to enrol in this study will undergo at least one radiotherapy treatment course which will involve attending 5 radiotherapy sessions scheduled 2-3x per week over 2 weeks. Radiotherapy will be delivered to specific sites of the body depending upon each individual's metastases. At the end of the treatment course, participants will be asked to undergo different types of CT scans and/or a PET scan to review the effect of the radiotherapy on the metastases. If required, participants may undergo an additional treatment course of 5 sessions after a four week break. This treatment process will then be repeated until all known cancer sites have been treated. At 12 months, 2 and 3 years after enrolling into the study, participants will also be asked to attend different CT scans and/or PET scan to review their cancer status and will also be asked to complete a questionnaire regarding their quality of life. It is hoped this research will determine whether the use of radiotherapy alone is effective in the treatment of cancer metastases in patients who are not able to receive oral and/or intravenous therapies.

  • Providing access to cognitive interventions for patients with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) in regional memory clinics

    This research aims to translate evidence-based cognitive interventions into regional clinical practice as post-diagnostic support for people at risk of dementia in regional Australia. It adapts an existing training package to build clinician capacity, while evaluating changes in clinician knowledge, skills, and confidence, as well as patient outcomes, and implementation barriers and facilitators to service delivery.

  • Corneal immune cell dynamics in contact lens wear

    Despite decades of advancements in lens technology to improve wearability and safety, contact lens (CL) discomfort remains a persistent challenge (at ~50% discontinuation). The primary reason is due to CL wear discomfort. The underlying mechanisms leading to CL wear discomfort remains poorly understood, although inflammatory processes have been implicated. Using advanced imaging techniques, with the Heidelberg HRT3 with Rostock Corneal Module, known as static and Functional In Vivo Confocal Microscopy (Fun-IVCM), this study will characterise the features of human corneal immune cells during soft silicone hydrogel CL wear, during typical daily wear (i.e., at timepoints over a diurnal cycle). This will be achieved by quantifying the density, morphology and dynamics of corneal immune cells in habitual asymptomatic and symptomatic CL wearers, as well as healthy controls who do not regularly wear CLs. The main aim of the study is to determine the relationship between corneal immune cell features and soft CL discomfort. The intervention will also be applied to assess whether there is a difference in the diurnal features of corneal immune cells with short-term lens wear (i.e., among a group of non-contact lens wearers who will wear the intervention for one day) relative to habitual contact lens wearers (comprising both individuals who are asymptomatic and symptomatic when wearing their existing/own contact lens products). The study will also assess whether anaesthetic, used as a standard procedure for in vivo confocal imaging, affects corneal immune cells. We will recruit 45 adult participants, aged 18-45 years, comprising healthy controls who do not wear CLs (n=15), as well as habitual asymptomatic (n=15) and habitual symptomatic soft CL wearers (n=15).

  • A Phase 1, Single-Dose, Open-Label, Randomized, Three-Period, Two-Sequence, Crossover Study to Evaluate the Relative Bioavailability of Paltusotine Low Drug Load (LDL) Tablets 60 mg (2 × 30 mg LDL tablet) and High Drug Load (HDL) Tablet 60 mg (1 × 60 mg HDL tablet) in Healthy Volunteers.

    This is a Phase 1, open-label, randomised, 3-period, 2-sequence crossover study of paltusotine tablets with two different drug formulations in a total of approximately 20 healthy male and female participants. This study is evaluating 2 formulations of paltusotine. Paltusotine is being developed as a potential new treatment for Acromegaly and Carcinoid Syndrome. Participants will be assigned to one of two treatment sequences with a minimum 10-day washout between each Period. In each dosing period, enrolled participants will receive a single dose of the following treatments per their assigned treatment sequence. -Treatment A (Reference): Participants will receive a single dose of 60 mg paltusotine, administered as 2 × 30 mg tablets after an overnight fast with a 4-hour postdose fast -Treatment B (Test): Participants will receive a single dose of 60 mg paltusotine, administered as 1 × 60 mg tablet after an overnight fast with a 4-hour postdose fast. Blood samples will be collected at multiple timepoints to assess plasma concentrations and calculate PK parameters. Safety and tolerability will be monitored through adverse events, laboratory tests, vital signs, ECGs, and physical examinations.

  • St. Vincent’s x Kieser Hip/Knee Osteoarthritis Waitlist Prehabilitation Study

    Osteoarthritis (OA) is a common condition affecting the hip and knee. Due to factors such as the ageing population and the increasing prevalence of obesity, the incidence of severe osteoarthritis is increasing. Severe osteoarthritis can warrant referral to an orthopaedic surgeon for an opinion on the appropriateness of total joint replacement as a management option. People with severe osteoarthritis often wait for long periods of time in the public health system before being seen by an orthopaedic surgeon. Before surgical intervention is considered, exercise programs to improve strength and function can help to alleviate symptoms and potentially improve outcomes following eventual arthroplasty surgery. The duration, quality, and effectiveness of currently available programs is varied. The literature suggests that exercise programs are more effective if they are supervised and if they are at least 12 weeks in duration given the time required for neuromuscular adaptation to take place. Kieser Australia has developed a 14-week supervised exercise program for people with hip or knee osteoarthritis on the waitlist to be seen by an orthopaedic surgeon for consideration of total joint replacement surgery. Aim - to determine the feasibility of the supervised exercise program in terms of recruitment rate, participant adherence, and participant retention.

  • Brain Station: a pilot lifestyle intervention for multiple dementia risk factors amongst culturally and linguistically diverse communities

    This project is a campaign called 'Brain Station' which will be launched as a mixed method quasi-experimental pre-post study taking place in multiple public locations. The primary aim is to empirically evaluate the impact of co-designed, culturally congruent dementia risk reduction public health campaign for ethnic communities on dementia risk. Secondary aims are to assess the impact of this campaign on ethnically diverse adults' dementia awareness and motivation. The project will recruit participants aged 18+ from English-speaking, Arabic, Chinese, and Vietnamese cultural backgrounds (N= 250 per group). Methods include a cross-sectional survey (baseline and 10-12 weeks post campaign), and qualitative interviews (n=60 (15 per language group), 10-12 weeks post campaign). This project will provide pilot data to scale our approach at a national and international level to support dementia prevention in culturally diverse communities.

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