ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Effect of strong magnetic fields on the communication between brain and arm after spinal cord injury.

    Recovery after spinal cord injury can be potentiated by repetitive transcranial magnetic stimulation (rTMS) of the brain. Current rTMS protocols use high stimulation intensities, which can cause discomfort, limit the application duration of rTMS and might cause unwanted stimulation of deeper brain areas. Preclinical work from our group has shown that low-intensity rTMS can induce plastic changes. In the current proposal we will test the safety and feasibility of a stimulation protocol mimicking that used in our preclinical work, and measure outcomes using robotics and neurophysiology.

  • The role of SGLT-2 inhibitors (Empagliflozin) in treating steroid induced hyperglycaemia in the management of glucocorticoid induced hypoerglycaemia in adults with and without diabetes.

    Availability of an oral tablet, empagliflozin (EG) is seen as a potential alternative to insulin injections for elevated glucose levels due to steroid treatment. We aim to investigate this. EG is already widely used for treatment in diabetic patients.

  • The Effects of a Multi–Component Intervention on Motor Skill Competency, Physical Fitness, Strength, Physical Activity Levels and Self Esteem in Preadolescent Females

    What is this project about? Western Australian children have significantly lower levels of motor skill competency, fitness, physical activity (PA) and sports participation compared to children 30 years ago. Research has found children below the proficiency level in motor skills are less likely to participate in lifelong PA or sport with females showing a greater decline than their male peers. Low levels of PA and cardiorespiratory fitness (CRF) have been shown to increase the risk for chronic disease in Australia. Preadolescent females are an important target group for changing PA activity habits as this age cohort will move into the crucial period of adolescence, where motor skill competency, weight status and body image can significantly influence self-confidence and psycho-social health. This project aims to determine whether a multi-modal intervention combining fundamental movement skills (FMS), high intensity interval training (HIIT) and strength training will improve preadolescent females’ motor skill competency, perceived motor skill competence, CRF, strength, weight status, PA levels, sport participation and psycho-social health. It also seeks to ascertain whether the intervention will result in increased levels of PA, sports participation and psycho-social health in the longer term so that it may increase lifelong PA and reduce the risk of chronic disease across the lifespan.

  • Behaviour Change for Physical Activity after Metastatic Breast Cancer

    The purpose of this study is to determine if a behaviour change intervention is effective in increasing physical activity in women with breast cancer. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with metastatic breast cancer (i.e. spread to the bones or one of the organs) and currently not a regular exerciser. Study details Participants will be randomly divided into two groups. Both groups will receive a Fitbit device and activity diary booklet, and take part in 6 weekly and 3 fortnightly calls over 12 weeks total. - For Group A, the phone calls will involve asking about their physical activity and cancer-related symptoms - For Group B, the phone calls will additionally include counselling for physical activity based on behaviour change theories. The majority of the project will be done over the phone or online, with the first and last sessions done in-person. Participants will need to complete assessments at baseline and after 12 weeks at the University of Sydney, involving physical assessments looking at fitness and physical function, and answering questionnaires. It is hoped that this research will help determine if a 12-week behaviour change program will result in changes in physical activity and quality of life for exercise.

  • Glue vs. Tacks in Mesh Fixation for Minimally Invasive Inguinal Hernia Repair – A Randomised Controlled Trial

    Keyhole inguinal hernia repair is a common operation which requires a netting mesh to reinforce the inguinal region. It may be fixed in the required position by sutures or metal/biodegradable tacks. An alternative to either of these is a cyanoacrylate glue which is a strong, inert plastic glue. Early studies show that it has the same fixation effect as other methods. It may have the advantage of reducing the operating time and avoiding damage to underlying structures (such as nerve or blood vessels) that sutures or tacks may cause. Our study aims to compare the use of glue to the current methods of fixation in keyhole inguinal hernia repair, particularly examining if it has the benefit of reducing groin pain for patients after the operation. We aim to randomly assign patients who have already agreed and consented to a keyhole inguinal hernia repair, to either glue or tack fixation for their mesh during their operation. All other aspects of their surgery and care will be the same. We will also review each patient’s wellbeing at the normal time points after the operation as we would for a standard inguinal hernia operation.

  • An Open Label Observational Study of Safety and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications

    This study is a multicenter, open label, longitudinal observational study aiming to assess the safety, tolerability and efficacy of MediCabilis™ when used at the prescribed dose by physicians for different indications using data reported by patients during treatment.

  • A Study of Lying Face Down to Help Improve Oxygen Levels of Adults Not Needing Ventilators in Intensive Care with COVID-19

    Prone positioning (lying face down) is a recognised rescue therapy for ventilated patients with severe lung disease whose oxygen levels remain low despite optimal ventilation strategies. We look to investigate whether proning early during admission to the Intensive Care Unit, might improve oxygenation for patient with COVID-19. Objectives: To determine the efficacy and safety of early prone positioning, compared to usual care, on oxygenation for non intubated adults admitted to ICU with COVID-19. Hypothesis: That the intervention (prone positioning) will improve measured oxygen levels in patients with COVID-19

  • An evaluation of the reliability and ease of use of a remote foetal heart rate monitor as used by expectant mothers at home. The HeraBEAT Trial

    Monitoring of the heartrate of the developing foetus (FHR) is an essential component of antenatal care. Monitoring FHR is currently restricted to in-clinic consultations with trained obstetric staff and appropriate medical equipment (hand-held doppler or cardiotocography (CTG)). The HeraBeat device is a new medical FHR monitor designed for use at home by the expectant mother, has been shown to be equivalent to existing gold standard FHR monitoring equipment and is approved for use in Australia. This study will examine the accuracy, usability and clinical utility of the HeraBeat device in the antenatal clinic and at home. This is a pilot study enrolling 60 participants. We will compare data accuracy against existing FHR monitors and assess usability of the device as rated by expectant mothers and antenatal clinic staff. More regular monitoring of FHR may result in improved pregnancy care.

  • The effect of the ABCDEF bundle on delirium, functional outcomes and quality of life in critically ill patients - a randomised controlled trial with embedded process evaluation

    The purpose of this study is to find out whether ventilated adult patients admitted to the Intensive Care Unit (ICU) who receive the ABCDEF bundle of cares will have reduced prevalence and duration of delirium, improved functional ability, and improved health related quality of life when discharged from the ICU and hospital compared to patients who receive our usual care. Delirium is an acutely disturbed state of mind characterised by restlessness, illusions, and incoherence. Functional ability relates to the participant’s ability to mobilise and care for themself, while health related quality of life relates to the impact of the participant’s health status on their quality of life. Mechanical ventilation, bed rest, the use of pain medication and sedatives are usual practices for some patients in Intensive Care Units (ICU). Unfortunately, these practices can be associated with both physical and psychological complications such as muscle weakness and delirium. The ABCDEF bundle of cares refers to: • Assess, prevent and manage pain • Both spontaneous awakening and spontaneous breathing trials • Choice of sedation and analgesia • Delirium: assess, prevent and manage • Early mobility and exercise • Family engagement and empowerment This bundle of cares involves using protocols that give the least amount of sedatives and pain relief necessary to keep the participant comfortable and settled, encourages early and safe weaning from the ventilator, mobilises the participant at the earliest and safest time, and aims to enhance family satisfaction with the participant care.

  • Lung ultrasound to predict invasive ventilation of patients with COVID-19 lung disease

    Lung ultrasound (LUS) is known to be more sensitive for detection of lung pathology compared to plain radiography and comparable to computerised tomography (CT), particularly for peripheral or pleurally based lesions. For example, it can be used in diagnosing interstitial patterns including pulmonary edema, as well as consolidation and effusions. Point-of-care (POCUS) is readily available in most emergency departments (ED), where it can immediately supply clinical information at the bedside. SARS-CoV-2 viral pneumonia (COVID-19) has led some practitioners to assess if LUS has utility in its diagnosis or prognosis. There are specific findings which represent viral pneumonias, such as increasing density of B-lines, subpleural consolidations, and absence of pleural effusions. Unfortunately LUS is currently unable to distinguish COVID-19 from other viral pneumonias but may be possible with further description of findings in a large cohort of patients. Although the current de facto “gold standard” for COVID-19 diagnosis, reverse-transcriptase polymerase chain reaction (RT-PCR) has a delayed turnaround of results and lacks sensitivity, particularly early in the course of the illness. Although LUS is unlikely to replace nucleic acid testing for definitive diagnosis, it may have utility in predicting clinical deterioration indicating need for ventilatory support. If proven to be accurately predictive of clinical deterioration, LUS findings could be integrated with clinical findings at the time of ED presentation, to triage patients to either outpatient management (low risk features), ward admission (moderate risk features) or intensive care unit (ICU) admission (high risk features). This could impact patient outcomes, resource allocation, and departmental flow, particularly in times of crisis. Furthermore, the findings from this study may inform the use of LUS in future respiratory virus pandemics.

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