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.
  • A randomized controlled trial of Theta Burst Stimulation for the treatment of mild to moderate Alzheimer’s disease

    There is an urgent need for the development of novel approaches to the treatment of Alzheimer’s disease (AD). AD is characterised by progressive decline in cognitive functioning in most areas, including in memory, attention, visuospatial ability, language and executive function. Although there are medications that can slow the progression of symptoms somewhat, there are currently no effective treatments for these hallmark symptoms of AD. Recent research has indicated that the progressive cognitive decline seen in AD may be a result of decreased functional connectivity throughout what is known as the default mode network (DMN), a brain network whose anatomy closely mirrors the pattern of cortical atrophy seen in AD patients (i.e. prefrontal, posterior parietal, and medial temporal). An approach that is able to specifically target this network in order to enhance connectivity, and thus functioning, could result in a highly effective therapy for the cognitive impairments in AD. Non-invasive brain stimulation (NIBS) techniques have considerable promise in this regard. NIBS has been shown to modulate activation throughout large scale cortical networks, such as the one implicated in cognitive impairment in AD, to enhance cognition in a number of disorders and to produce long lasting behavioural effects. In particular, Theta Burst Stimulation (TBS) is a highly effective form of NIBS and allows for multi-site stimulation within a single treatment session. The use of TBS for the treatment of cognitive impairment in AD is an area of significant potential, and one that has yet to be adequately explored. We propose to conduct a double-blind placebo-controlled randomised pilot study comparing a treatment course of active TBS to sham TBS (i.e. 21 daily treatment sessions over six weeks). In each treatment sessions TBS will be sequentially provided to four brain regions, the left and right dorsolateral prefrontal cortex (lDLPFC, rDLPFC) and the left and right posterior parietal cortex (lPPC, rPPC).

  • A Randomised Controlled Trial of Hypnosis for Acute Burn Pain

    Burn injuries and treatment often cause excruciating pain for patients. Hypnosis has demonstrated benefits in treating pain in addition to pharmacological pain management. However, psychological pain management techniques are not currently used in standard pain management protocols on burns units. Audio recordings could be an efficient way for patients to access these treatments, and nurses may be well-positioned to assist patients to use them, as they spend more time with the patient than other clinicians and are usually present during wound dressing changes. The aims of this project are: 1. To explore the feasibility of using audio recordings of hypnosis as an adjunct to pharmacological treatment of burn pain. 2. To explore the feasibility of nurses assisting with the administration of hypnosis recordings. Adults over 18 years of age who are admitted to the burns unit with an injury that requires surgery will be screened and those who are eligible will be invited to participate in the study. Pain, anxiety and relaxation will be measured for all participants during a dressing change to give baseline information. Then patients in an experimental group will be asked to listen to a 25 minute recording of hypnosis 5 times to practice before using the recording in a further dressing change. Those in a control group will receive standard care during their dressing changes. After dressing changes patients will be asked to rate their pain, anxiety and relaxation experience. Nurses will administer the recordings. The experiment will follow a repeated-measures between groups design, which means that pain, anxiety and relaxation ratings and personality measures can be compared between the groups before and after treatment. Results will provide information about the benefits of hypnosis and mindfulness audio recordings for patients on the burns unit, and the feasibility of using nurses to administer these. They will also provide valuable information about personality variables that influence how well someone will benefit from either treatment, which will assist with treatment planning.

  • The community-based physical activity study for adults with type 2 diabetes, at high risk of Type 2 diabetes or overweight /obese.

    The aim of this randomised controlled trial is to develop, implement and evaluate a community-based intervention to promote physical activity among adults diagnosed with Type 2 Diabetes, at high risk of Type 2 Diabetes or overweight /obese. The 20-week intervention will include five sessions with a qualified personal trainer and a smartphone App. Aerobic fitness, muscular strength, physical activity, functional mobility, BMI, waist circumference, blood pressure, and cognitive variables will be assessed. Assessment will be conducted at baseline, 10-weeks and 20-weeks.

  • The SIESTA trial - a randomized Study Investigating the Efficacy, Safety and Tolerability of Acupressure versus sham therapy for improving sleep quality in patients with end-stage kidney disease on haemodialysis

    This study aims to determine whether acupressure therapy will be able to improve sleep quality in patients receiving haemodialysis (HD) or haemodiafiltration (HDF) for treatment of end stage kidney disease (ESKD). Other outcomes include change in quality of life, adverse reaction at the site of acupressure application and patient acceptability.

  • The Effects of High-Fat Availability on Muscle Growth Responses to Exercise and Nutrition.

    The ingestion of excess energy, particularly fat, is largely responsible for the current epidemic of lifestyle-related diseases such as obesity, diabetes and sarcopenia (the progressive loss of muscle mass with increasing age). The development of sarcopenia is exacerbated by low levels of physical activity and also in overweight or obese individuals through an increase in body fat and concomitant decrease in muscle mass. However, performing resistance and aerobic exercise in combination with the ingestion of high-quality protein sources (e.g., dairy-based protein) has been shown to enhance and/or maintain muscle mass. This has important health implications for reducing the risk of developing sarcopenia, obesity or other debilitating health conditions such as diabetes. Accordingly, the aim of this research is to investigate whether high fat levels decreases the muscle growth response following resistance and endurance exercise and protein ingestion.

  • Study of PAX-1 in Patients With Persistent Cancer Pain in the Palliative Setting

    The purpose of this study is to assess if the drug, PAX-1, can reduce cancer pain when used in addition to usual pain medication. It will also assess the side effects it may cause. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are experiencing moderate or severe, persistent cancer-related pain are in the palliative setting. Study details: Participants in this study will be randomly (by chance) allocated to one of four groups. Participants in three of the groups will receive the study drug, PAX-1, at a dose of either 7.5mg, 10mg, or 12.5mg . Participants in the fourth group will receive a placebo (inactive) tablet. The tablets are taken orally 3 times a day for 28 days. All participants will continue to take their usual pain medication in addition to the study medication. They will not know to which group they have been allocated until after the study. Participants will be asked to record their daily pain intensity on a numerical rating scale. They will also be asked to complete questionnaires on appetite, sleep quality, functional status, and quality of life and will undergo safety and tolerability evaluations involving blood tests, ECGs and monitoring of adverse events. This will enable us to determine the clinical benefit of PAX-1 for cancer patients in the palliative setting.

  • Relationship between neutrophils, airway function and remodelling in older people with asthma.

    Fixed airway narrowing is a common complication of long standing asthma. It occurs despite good treatment with puffers that are effective in controlling inflammation. It causes symptoms such as wheeze, cough, shortness of breath and there is no known treatment for asthma related fixed airway narrowing because the mechanisms and causes are poorly understood. It is more common in older patients who have had asthma for many years, in whom there are also greater symptoms. Airway inflammation due to neutrophils is more common in older people with asthma who have fixed airway narrowing. Neutrophils are a type of cell that are part of the body's immune system which causes inflammation. Neutrophilic airway inflammation can cause damage to the airways and lung tissue. The aim of this research is to determine how neutrophils affect the function of the smaller airways in older people with asthma. We will also determine how neutrophils cause airway and lung damage, which can lead to fixed airway narrowing. We will recruit people with asthma who are >40 years of age, are non smokers and have no other significant lung or heart problems. Participants will undergo breathing tests and a bronchoscopy, using a small camera on the end of a flexible tube, to obtain samples from their lungs. The significance of this study will be the discovery of the mechanisms that underlies this major complication of asthma. It will assist in overcoming the major barrier halting progress to an effective treatment strategy for which the mechanisms are unknown.

  • A Phase I study of orally inhaled PB01 in healthy male participants following single and repeat administration.

    This study is designed to assess the safety, tolerability and pharmacokinetic profile of orally inhaled PB01 when administered to healthy male volunteers (aged between 18 and 55 years) as a single dose (Stage 1 component of the study) and 14 consecutive once daily doses (Stage 2 component of the study) at dose levels up to 30 mg. Stages 1 and 2 will be conducted in Australia.

  • Development and validation of basketball and netball specific injury prevention tools

    It has been suggested that faulty biomechanics contribute to the high rate of lower extremity injuries in basketball and netball. This project will involve a cluster randomized controlled trial that will investigate if a sports-specific injury prevention program results in changes in landing biomechanics among netball and basketball players.

  • Oral paracetamol versus intravenous indomethacin for the treatment of patent ductus arteriosus in premature infants: A Randomised Control Trial (The OVID Trial)

    This will be a placebo randomised control trial conducted in the neonatal intensive care unit. The trial will compare oral paracetamol against current standard therapy for a haemodynamically significant ductus arteriosus, which is intravenous indomethacin.

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