ANZCTR search results

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

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31913 results sorted by trial registration date.
  • Home strengthening exercise for knee osteoarthritis: the FRESH randomised controlled trial

    Participants will be randomly allocated in a 1:1 ratio to receive the same home strength program prescribed either i) once a week or ii) three times a week. Participants in both exercise groups will receive one videoconferencing consultation with a physiotherapist (within one week post-randomisation, 30 minutes). The physiotherapist will prescribe the same 5 standardised exercises to all participants at a standardised dosage of 3 sets of 12 repetitions per exercise. The physiotherapist will instruct the participants to perform their exercise program unsupervised at home, at their allocated weekly frequency, until the 3-month reassessment. The time point for re-assessment will be 3 months post-randomisation. The primary outcome measure will be the change in average walking pain over the past week on an NRS. Secondary outcome measures will include WOMAC pain and function; quality-of-life; arthritis and exercise self-efficacy; global rating of change; patient specific functional scale; patient acceptance of symptoms; sit to stand test; calf raise test; and willingness for joint replacement. We hypothesise that a strengthening exercise program prescribed once a week is non-inferior to the same home program prescribed three times a week in people with knee OA.

  • Sapu003 in Combination with Exemestane in Post-Menopausal Women with HR+, HER2-Negative Advanced or Metastatic Breast Cancer

    This study aims to find the safest and most effective dose of a new investigational drug called Sapu003 (Everolimus) when given together with exemestane in women with advanced or metastatic breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2–). Who is it for? You may be eligible for this study if you are an adult woman aged 18 years or older, you are post-menopausal (no periods for more than 12 months), and you have been diagnosed with Stage 4/metastatic or locally advanced breast cancer that is HR+ and HER2-. You may also be asked to complete additional health checks with a study doctor to determine if you are able to enrol in this study. Study details All participants who choose to enrol in this study will be allocated to a treatment group to receive a dose of Sapu003 (Everolimus) that will be given intravenously (via a vein) once a week for a 4-week cycle. Participants who don't experience any dangerous side effects will be asked to continue receiving Sapu003 each month for up to 6 months. All participants will be asked to take a single oral dose of exemestane daily throughout their time in the study so that any drug interactions between exemestane and Sapu003 can be studied. Higher doses of Sapu003 may be studied if the initial participant group reports no dangerous side effects. Participants will also be asked to provide additional blood samples throughout the study and to report any side effects they experience while taking the study drugs. It is hoped this research will determine a safe dose of Sapu003 for future trials and to see whether the combination of Sapu003 and exemestane shows promise in controlling cancer spread in patients with HR+/HER- breast cancer who are also post-menopausal.

  • Health Innovation - Transformative Interconnected Digital Ecosystem (HI-TIDE): Effect of advanced videoconferencing and emergency telehealth services on emergency patient transfers from remote locations.

    The HI-TIDE Research Project involves the evaluation of the implementation of an advanced videoconferencing and emergency telehealth service at selected remote Western Australian health services. The project will consist of two phases - an initial community consultancy phase to co-design and finalise the evaluation process, followed by implementation of evaluation tools and framework. The evaluation will evaluate the experiences of patients, carers and staff in healthcare, and changes in health system outcomes resulting from the implementation of the technology. The results will inform how best any further implementation should proceed.

  • Using non-contact imaging to compare the positioning of different stents in glaucoma patients

    The aim of this study is to compare the positioning of the Hydrus Microstent and iStent Infinite devices after insertion into the eye for patients undergoing routine glaucoma surgery. It is predicted that by using a specialized camera to take high resolution images of the eye, the positioning of the devices will be able to be more precisely compared. The positioning of the devices will be examined at 3 months post insertion using a specialized camera which takes high resolution pictures of the eye.

  • Feasibility of functional magnetic resonance Imaging GUided Radiation therapy dose Escalation in Head and Neck Cancer patients (FIGURE-pall HNC)

    This study is testing whether an advanced type of MRI scan (called diffusion weighted MRI) can be used to guide and safely increase radiation doses to “high-risk” areas of head and neck cancers, with the aim of improving tumour control while still protecting surrounding healthy tissue. Who is it for? Adults aged 18 years and older with squamous cell carcinoma of the head and neck, or with large nodal metastases suspected to be from the head and neck region, who are not eligible for curative treatment. Participants must be able to give informed consent. Study details Before radiotherapy planning, participants will attend an MRI scan at Sunshine Coast University Hospital, lying in the treatment position with a fitted mask. This scan takes up to one hour. Radiation therapy will then be delivered using the palliative schedule (four treatments per cycle, 3 cycles in total with 1 month gap in between). An extra “boost” dose of radiation will be targeted at the high-risk tumour area identified on the MRI. Each treatment lasts about 15 minutes. Participants will also complete short quality-of-life questionnaires before, during and after treatment (about 10 minutes each). The study will closely monitor side effects during and after radiation treatment. It is hoped that this approach will improve control of head and neck cancers and patient quality of life without adding significant treatment burden.

  • Clinical Pilot Study of the Diabetes Body Project for Australian Adolescents with Type 1 Diabetes: Addressing Disordered Eating in a Paediatric Diabetes Setting

    Adolescents living with type 1 diabetes (T1D) are 2-3 times more likely to develop disordered eating behaviours (DEB) than their peers without T1D. T1D guidelines recommend routine screening for DEB from 10-12 years, yet an early intervention model for treating DEB in adolescents is lacking. The Diabetes Body Project (DBP) is a virtual care early intervention model for treating DEB. The DBP has been developed and piloted internationally in a cohort of adolescent and young adult females with T1D, showing promising patient experience and clinical outcomes such as reduced DEBs. This project seeks to be the first to adapt the DBP for implementation in an Australian paediatric clinic and evaluate its’ acceptability, feasibility, and preliminary efficacy in an exclusively adolescent population. Additionally in line with model of care we seek to evaluate a parent/carer group to support the adolescent intervention.

  • efficacy of TrAnsauricular Vagal Nerve Stimulation to reduce postoperative delirium severity: a double-blind randomised, sham-controlled feasibility study (TAVerNS)

    Double-blind randomized sham-controlled trial. Transcutaneous auricular vagal nerve stimulation (taVNS) is a safe, non-invasive neuromodulation technique that delivers electrical stimulation to the auricular branch of the vagus nerve via electrodes placed on the tragus of the ear. Vagal nerve stimulation (VNS) is known to provoke brain arousal via release of noradrenaline and acetylcholine in cortex. Given there are no treatments for delirium, taVNS represents a paradigm shift in the approach, and would avoid polypharmacy effects that often contribute to treatment complexities in acutely ill older adults.

  • Intravenous Lignocaine for Acute Migraine

    This study is testing whether intravenous (IV) lignocaine, a medicine normally used as a local anaesthetic, can help relieve severe migraine attacks in the Emergency Department. Adults who come to hospital with migraine that has not improved with their usual treatments may be invited to take part. Participants will receive lignocaine through a drip over one hour, together with a routine medicine called dexamethasone, and their pain and side effects will be closely monitored. If the migraine does not improve after two hours, standard treatments will still be provided. The aim of this pilot study is to see if IV lignocaine is safe, practical to use, and shows early signs of effectiveness, so that larger studies can be planned.

  • Moving Without Fear When Living with a Stoma: A Consumer-Led Physical Activity Study

    This study aims to co-design and test a telehealth-delivered, stoma-specific exercise and physical activity program to ensure it meets the needs of people living with a stoma. Who is it for? You may be eligible for this study if you are: A male or female age 18 or older, who has received a stoma as a result of Inflammatory Bowel Disease (IBD) or cancer in the five years prior to enrolment. A stoma is either permanent or long-term. Have access to the internet and own, or have access to, a computer or tablet device. or, A health professional working with people who have a stoma Study details: Participants will be involved in different ways depending on their group: Consumers with lived experience of a stoma will help co-adapt and refine the FOXTROT X exercise intervention through an interactive series of workshop sessions. Healthcare professionals will also assist in co-adapting the FOXTROT X exercise intervention during a collaborative workshop with consumers. People with a stoma due to cancer will test the 12-week exercise program (delivered via telehealth), followed by a 12-week maintenance period. Participants will also complete quality of life assessments and may undergo simple health checks, such as surveys. There is no randomisation — all eligible participants will receive the intervention or be involved in its design and evaluation. It is hoped that findings from this study will enhance physical activity and quality of life in the stoma community.

  • Does priming the brain with aerobic exercise increase arm recovery from a stroke rehabilitation program?

    Stroke rehabilitation remains limited in effective solutions for upper-limb recovery. Two key approaches include providing high doses of intensive training and leveraging strategies that harness neuroplasticity. Aerobic exercise has gained increasing attention for its ability to enhance neuroplasticity and accelerate motor learning. Evidence suggests that moderate and high-intensity exercise can increase excitability within the primary motor cortex in the chronic phases of stroke. Such evidence warrants further investigations into whether such aerobic exercise paradigms may increase the brain's responsiveness to rehabilitation. Therefore, this study seeks to investigate the feasibility of whether high-intensity interval training or moderate-intensity training on a recumbent exercise bike, 30 minutes before therapy, 3 days a week, over a 5-week intensive rehabilitation program, may help prime the brain for rehabilitation and further improve clinical outcomes in chronic stroke.

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