ANZCTR search results

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

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33578 results sorted by trial registration date.
  • Effectiveness of app-delivered tinnitus therapy

    This study aims to evaluate the effectiveness and app usability of a smartphone app (Oto) in tinnitus management. Oto is a novel multimodal app-delivered approach to tinnitus available for iOS and Android. It combines patient education, cognitive behavioural therapy (CBT), relaxation, mindfulness, and sound therapy in a customisable package. Oto has received Medicines and Healthcare products Regulatory Agency (MRHA) certification as a Class 1 medical device in the UK. This study will test the hypothesis that the use of Oto will significantly reduce tinnitus severity than receiving no tinnitus intervention (i.e., being on a wait list).

  • Fluids in Labour EnsUring Maternal Euvolemia (FLUME): Co-design study and pilot randomized controlled trial for oral hydration for nulliparous women undergoing induction of labour

    This is a two-part study which involves two aims: 1. To develop a consumer- and evidence-informed maternal intrapartum hydration assessment and management intervention protocol for nulliparous women undergoing induction of labour which maintains maternal euvolaemia during parturition. 2. To evaluate the feasibility of undertaking a randomised control trial of the intervention developed in stage one with nulliparous women undergoing induction of labour within the RBWH.

  • ORganoId GuIded N-of-1 (ORIGIN-1) Trial: A phase 4 study to investigate whether people with cystic fibrosis (CF) with rare cystic fibrosis transmembrane regulator (CFTR) mutations who have an in vitro response to Trikafta will also have a clinically meaningful response to Trikafta versus placebo

    This study aims to evaluate whether an in vitro test enables identification of people with Cystic Fibrosis rare mutations who are clinically responsive to CFTR modulators. Cystic Fibrosis patients with two non-F508del mutations with a positive response in the in vitro testing will undergo cycles of treatment with a triple combination -Elexacaftor/Tezacaftor/Ivacaftor (Trikafta) and matched placebo. Short term improvement in lung function (FEV1) and CF-related symptoms will be used to determine if they respond to the treatment.

  • Measurement of involuntary muscle contraction in adults with spasticity

    This study aims first, to objectively measure co-contraction phenomena during a functionally based repeated grasp and release task in adults with UMN syndrome resulting from a neurological diagnosis. Second, to demonstrate the relationship/impact of abnormal muscle co-contraction on everyday function. Finally, this study aims to objectively measure change in maladaptive co-contraction following OnabotulinumtoxinA injection. This study will contribute to the body of knowledge regarding the pathophysiology of maladaptive muscle co-contraction and explore the impact of co-contraction on everyday function.

  • A music intervention for consumer and staff wellbeing in an advanced dementia unit.

    MATCH is an eHealth solution, “Music Attuned Technology Care via eHealth,” developed to support carers of people living with dementia to use music intentionally to support care. It is a scalable solution for the growing number of people living with dementia. We developed the ‘MATCH Music Training Program’ as part of this package, which we will trial in a hospital setting in this study.

  • A Randomised Clinical Trial of a digital Self-Management package for people with Interstitial Lung Disease (REBUILD-SM trial)

    The REBUILD-SM trial will evaluate the efficacy of a combined self-management package and smartphone application for people with interstitial lung disease (ILD). This intervention will be supported by phone calls from health professionals. Participants will be allocated to either the intervention or control group and take part in the 12-week intervention, with follow-up at 6 and 12 months. It is hoped that the intervention will improve health-related quality of life for people with ILD by helping them better manage their chronic condition.

  • ENRICH ME STUDY- Examining the impact of an Early Intervention on incidence of poor cardiovascular health outcomes in women with pre-eclampsia and gestational hypertension.

    A diagnosis of pre-eclampsia or gestational hypertension have long-term implications for women's health, with an associated increase in lifetime risk of ischaemic heart disease, stroke, and heart failure. Research suggests earlier cardiovascular risk assessment for women with a history of hypertensive pregnancy disorders would likely benefit from establishing care with a cardiologist before the age of 45 to optimise modifiable risk factors and initiate primary prevention strategies to reduce cardiovascular disease. Behavioural science studies have also shown that positive behavioural changes are more likely when individuals are already undergoing significant life changes. This study aims to review if early intervention of diet and lifestyle counselling and cardiovascular assessment. help improve cardiovascular outcomes in women post delivery of their baby. Through two post natal cardiovascular follow up visits one at 3 months and one at 9 months post delivery and if necessary a review with a cardiologist.

  • Evaluating the Effect of Endocrine Therapy on Gut Bacteria in Estrogen Receptor-Positive Breast Cancer

    This study aims to identify gut bacteria that are associated with vasomotor symptoms, such as hot flushes, that affect quality of life for women with breast cancer. Who is it for? You may be eligible for this study if you are a female who has either been diagnosed with estrogen-receptor positive breast cancer postmenopausally and are due to receive endocrine therapy, or are a carer for a breast cancer patient. Study details While breast cancer patients undergo the standard 5 to 10-year regimen of endocrine therapy, participants will be requested to provide blood and stool samples, along with completing questionnaires before and during the treatment (at week 4-5 and week 12). Healthy caregivers in the control group will not undergo any treatment, however, they will be requested to provide samples and complete questionnaires at a single time point before the individual under their care undergoes endocrine therapy. It is hoped that findings from this novel study will help to identify key gut bacteria associated with vasomotor symptoms to improve the quality of life and increase the survival of breast cancer survivors.

  • Un-Necessary Tests in Emergency Departments (UNTIE), a Stepped-wedge Cluster Randomised Trial

    Hypothesis: We hypothesise that audit-feedback will be more effective than usual practice in improving appropriate pathology test ordering in Emergency Departments, as measured by a reduction in UNTIE-U and an improvement in UNTIE-N. Population: All consecutive ED visits at Auburn, Blacktown/Mount Druitt, Nepean, and Westmead Hospital Emergency Departments over the fifty-week study period, where the patient presentation maps to one of the 29 clinical presentations covered by the 2023 ACEM–RCPA Pathology Testing in the Emergency Department guideline. Intervention: Automated generation of UNTIE-U and UNTIE-N scores for each eligible presentation, derived from routinely collected pathology and administrative data. Following randomisation to the intervention phase, scores are presented to clinical staff via a multimodal audit-feedback program delivered fortnightly, including face-to-face sessions, recorded presentations, emails, and visual prompts. UNTIE scores continue to be collected throughout the intervention period to monitor departmental performance. Comparison: Usual clinical practice. Sites in the control phase receive no audit-feedback contact from the research team. The control is concurrent rather than historical, as all sites begin in the control phase and cross over to the intervention at ten-week intervals. Outcome: The primary outcome is UNTIE-U and the secondary outcome is UNTIE-N. Both will be generated blinded to an ED's intervention/comparator status.

  • Effects of Sports-Hydration Drink on Infantry Soldiers

    A novel hydration strategy will be investigated as an aid for the maintenance of hydration status in austere environments. The novel hydration strategy (beverage) employs resistant starch (in the form of high amylose maize) as well as glucose and electrolytes. Previous research has shown that resistant starch may increase water absorption in the large intestine, capable of absorbing upwards of 6L/day. This study aims to assess: -Whether a hydration drink containing resistant starch improves the hydration of personnel immediately before training and during recovery -Whether a hydration drink can improve gut health It is hypothesised that the resistant startch hydratation drink will improve the hydration status of military personnel undertaking high levels of physical activity in a hot tropical environment.

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