ANZCTR search results

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

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32704 results sorted by trial registration date.
  • BreastScreen trial of hybrid tomosynthesis versus mammography screening

    This prospective comparative trial embedded in population-based screening, at Maroondah BreastScreen, Eastern Health, will examine screening outcomes of hybrid digital breast tomosynthesis/mammography compared to digital mammography screening (standard of care) in women presenting for routine breast screening. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above and are attending a BreastScreen service at Maroondah BreastScreen. Study details Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention in this study is digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammography’ screening or the ‘intervention screen’ in this trial. Other aspects of screening and assessment, and any required follow-up, will be based on standard BreastScreen protocols and quality assurance processes. The trial will assess initial detection measures (cancer detection, and recall for further testing) as well as outcomes at follow-up (to determine interval cancer rates).

  • Investigating the proposed effect of low-level laser therapy in providing pain relief in human teeth

    This project will be built upon a recently published systematic review that the project investigators have conducted. This study is being completed as part of Dr Sachin Kulkarni’s Doctor of Philosophy (PhD) program at Griffith University. Purpose of the study: To determine the efficacy of Photobiomodulation on providing anaesthesia of teeth. Fear of dental aesthetic injection can produce anxiety and contribute to dental phobia. Recently, other methods have been studied for their effectiveness to produce anaesthesia. One such method is known as Photobiomodulation. The purpose of this study is to utilise laser to assess where the sensitivity of the nerve inside the tooth reduces. Public: The purpose of this study, or hypothesis, is that the laser devices should produce some amount of pain relief as tested with a commonly used dental nerve testing device.

  • A risk-guided strategy for Acute Decompensated Heart Failure using mHealth.

    The aim of this study is to evaluate the impact of Smart-HF (a mHealth platform) on reducing readmission to hospital and other secondary outcomes. The Smart-HF platform is an app for the patient that delivers educational information, goal-setting, homework tasks, self-monitoring and questionnaires to patients with heart failure, and allows patient progress and outcomes to be measured via a clinician portal. Participants are patients admitted to the general or cardiology wards with Acute Decompensated Heart Failure (ADHF). Enrolled patients classified with a high risk of hospital readmission and/or death - i.e., equal to or greater than median of predicted risk, 33% based on the TAS-Help study algorithm developed by CIs Marwick and Huynh - will be randomised to either usual care or Smart-HF plus usual care, with stratification by study site and type of HF (reduced or preserved ejection fraction). The primary endpoint is quality of life at 90 days post hospital discharge. Secondary endpoints - 30-day readmission, 30- and 90-day composite outcome.

  • Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE): Investigating the impact on quality use of medicines

    High and variable rates of psychotropic medication use persist in residential aged care facilities (RACFs) despite minimal evidence of benefit and increasing evidence of harm. Knowledge brokers are individuals or groups who facilitate the transfer of knowledge into practice. This study will employ an onsite pharmacist to act as a knowledge broker to implement new Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (the Guideline). The intervention will involve the delivery of three implementation strategies: Level 1 - passive distribution of the Guideline; Level 2 - current best practice; Level 3 - employment of a knowledge broker. Each RACF will receive each strategy for one of three psychotropics medication (antipsychotics, benzodiazepines and antidepressants). In the level 3 strategy, the knowledge broker will develop an action plan and will undertake a variety of ongoing local activities to facilitate implementation of the Guideline. It is hypothesised that the level 3 intervention knowledge broker will lead to improvements in Guideline concordant use of antipsychotics, benzodiazepines and antidepressants in RACFs compared to the other two levels.

  • A trial to evaluate a best practice cardiogenic shock care pathway vs standard care on equity and patient outcomes in Cardiogenic Shock:

    ESCAPE-CS is the implementation of an evidence-based, best-practice Cardiogenic Shock care pathway that is hypothesised to improve mortality, safety, healthcare utilisation and QoL outcomes, and reduce inequity in access to care. It is a multicentre, two-phase prospective cohort study. Phase 1, a 12-month data collection of ‘usual care’ phase, is followed by Phase 2, a 12-month study intervention phase. The study intervention has three components: a streamlined referral system, a multidisciplinary shock team, and protocol-driven care. The study will be conducted in 7 participating centres across local health districts in NSW. These centres encompass a range of urban tertiary and non-tertiary, regional and rural sites, and have existing referral relationships with either a quaternary centre or another participating centre in the study.

  • Educational intervention related to nursing care of haemophilia patients

  • 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.

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