ANZCTR search results

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

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31212 results sorted by trial registration date.
  • Electroanatomical Remodeling of the Atria in Obesity: Impact of the Adjacent Epicardial Fat

    The study aims to delineate the electroanatomical remodelling in obese patients with atrial fibrillation. Importantly, it will analyse the impact of contiguous epicardial fat deposits on the electrophysiological properties of adjacent atrial tissue. It is a retrospective study based on the analysis of prospectively collected database. The patients underwent cardiac MRI prior to the ablation. Electrical remodelling and fat deposits and their association will be analysed

  • Smoking cessation and effects of cigarette smoking on cure and side effects of treatment in patients with cancer in the head and neck region.

    This observational study will evaluate smoking cessation and its impact on treatment outcome and survival in patients with head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have a confirmed diagnosis of Stage I-IV squamous cell carcinoma of the oral cavity, pharynx, larynx, nasal cavity or paranasal sinuses, for which you are deemed suitable for curative treatment at Townsville Cancer Centre. Study details Participants will undergo cancer treatment and may participate in the existing smoking cessation program as per standard of care at Townsville Cancer Centre. They will then be followed up at 3 months, 6 months, 9 months, 1 year, 2 years, 3 years and 5 years post treatment to evaluate a number of outcomes, including smoking cessation rate among smokers, treatment toxicities, and clinical response to treatment. It is hoped that the results of this study will help inform patients and health care providers and facilitate improvement in quality of care and patient compliance leading to improved disease control, survival and quality of life.

  • HABIT-ILE: A randomised trial of hand arm bimanual intensive training including lower extremity training for children with bilateral cerebral palsy

    In Australia, 35,000 people have cerebral palsy (CP), and between 60-70% of these have difficulties with movement on both sides of their body. There are currently no effective interventions for children with CP that affects both sides of their body to improve their ability to use their hands, walk and perform daily life tasks. We will test the efficacy of Hand Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE), in 126 children with cerebral palsy and compare results to usual care.

  • A randomised controlled trial of an automated SMS messaging tool in the use of asthma plans in a patient population attending a busy suburban Brisbane General Practice

    We know that asthma is a common but serious illness that causes deaths in otherwise healthy people, including young people and children. While asthma can’t be cured, it can be managed but this does require regular review of symptoms and medications, particularly because the disease can vary in severity over time, with different triggers affecting this. One strategy to improve asthma management is an asthma action plan. This is a written document that outlines how a patient’s asthma can be managed. It is individualized for each patient, and for different levels of asthma severity. It has been shown that having an asthma action plan reduces asthma mortality, yet many patients with asthma do not have a current up-to-date action plan. Part of the reason for this is that many patients with asthma only attend when they are unwell and do not attend for a planned visit to review their asthma care. Our aim is to see if a simple short messenger service (SMS) sent by the GP clinic (Banyo Clinic) increases the number of patients who attend for a planned asthma review, and as such get a current asthma action plan as part of this. To do this, we plan to design and use a computer program to search the existing general practice database and identify those patients with asthma who are eligible. Performing such a search and identification is a usual part of good practice care and clinicians regularly carry out similar audits of their databases. In this project, we additionally wish to send a SMS message to half of the population identified, inviting them to book an appointment for an asthma review. The other half of the population won’t receive an SMS and therefore will receive usual care. After two months, we will send a follow up reminder SMS to those who haven’t attended for an asthma visit with the same SMS reminder. After data collection, we will analyse the data to see if the group who received the SMS attended at a different proportion to the control group for asthma visits and supply of action plans. Our hypothesis is that, compared to usual care in the control group, receiving an automated SMS reminder prompting patients to attend for an asthma management review will: 1: Increase the attendance at the clinic for a planned asthma review 2: Increase the proportion of patients with asthma management plans The population target will be active patients with asthma who have attend the Banyo Clinic at least twice in the preceding two years who have a mobile phone number attached to their file. Eligible participants will be defined as those who have asthma in their active past history. Participants will be identified from the clinic's data base and recruited by mail from the clinic. It is estimated that there will be approximately 300 eligible people in both the control group and the intervention groups. The participants will be randomized by computer to either the intervention (SMS receiving group) or the control (care as usual) group.

  • Measuring skin and tissue change before and after compression: a comparative study of people with and without primary lymphoedema

    Primary lymphoedema occurs in people with a genetic predisposition and manifests as long-term swelling of a body part. Current assessments provide little understanding of the composition of the underlying tissues and how they respond to treatments. No information has been available about the difference between those with and without lymphoedema with respect to age and skin properties. This study will use high frequency ultrasound (HFU) to investigate differences in skin composition and thickness in people with and without primary lymphoedema. The measures to be used include clinical tools which measure dermal properties (skin resistance and elasticity, and measures of water content and limb volume). The response of the skin to compression, a standard lymphoedema intervention, will then be assessed with HFU and clinical assessment tools, following the application of intermittent pneumatic compression. Children and adults with and without primary lymphoedema, aged between three and 40 years old, will be included. Analysis of clinical tools for a measure of equivalence with HFU findings will inform the use of clinical tools and enable translation of study findings to the clinical setting. Compression is used in healthy populations to support limbs during travel and sport: inclusion in this study of both the healthy population and the understudied childhood lymphoedema population will add to the understanding of the effect of compression on the skin for all groups and form the basis for targeted treatment guidelines. Most lymphoedema research has investigated secondary lymphoedema, despite there being strong growing evidence of underlying genetic predisposition or covert primary lymphoedema in those who develop secondary lymphoedema. The findings of this study will provide a basis for understanding the progression of primary lymphoedema and inform future primary and secondary lymphoedema research.

  • Comparing two approaches (Cogsmart and CirCuits) to improving the cognitive deficits of people diagnosed with psychosis.

    This clinical trial will look at which of the two therapies works best in improving thinking skills (e.g. memory and attention) which influence real world functioning. The two therapies are Cognitive Symptom Management and Rehabilitation Therapy (Cogsmart) and Computerised Interactive Remediation of Cognition – Training for Schizophrenia (CIRCuiTS). Cogmsart is a group therapy that aims to improve real world thinking skills for functioning. CIRCuiTS is a computerized program with modules including tasks of a wide range of cognitive functions. It also includes “bridging” were participants in the group reflect on how the program relates to thinking skills needed in real world functioning. What are the possible benefits of taking part? We cannot guarantee or promise that you will receive any benefits from this clinical trial; however your participation will help us better understand if Cogsmart and CIRCuiTS are effective in improves thinking skills that help in every day functioning for people who suffer from psychosis. What does participation in the study involve? This clinical trial will randomise participants in a 1:1 design, which means there is an equal chance of being in either the Cogsmart or CIRcuiTS group. Step 1 Screening Process To determine Initial study eligibility you will partake in a screening interview which will take approximately 30 minutes. Step 2 Contact You will be asked to attend group sessions either once a week for 12 weeks, with each session lasting approximately 2 hours, or twice per week for 12 weeks, with each session lasting approximately 1 hour. You will also be asked to attend three sessions as an individual. At each individual session a clinical trial research assistant/psychologist will conduct a series of clinical assessments. This will involve asking questions about your thinking and problem solving skills, thoughts, symptoms, and relationships.

  • Outcomes evaluation of the Victorian Healthy Homes Program: a staggered parallel group cluster randomised controlled trial assessing the thermal comfort and health benefits of home energy efficiency improvements

    The Victorian Healthy Homes Program will focus on better understanding the combined health and energy outcomes of household energy efficiency retrofit programs targeted at vulnerable householders. The evaluation will also include health economics analyses. The two overall aims for the outcomes evaluation of the Victorian Healthy Homes Program are to: (1) measure the health and energy co-benefits of improved thermal comfort among low-income households where at least one person has an existing health need and (2) provide a monetarised estimate of these health and energy co-benefits to inform future government household energy efficiency policy and programs.

  • My Exercise My offspring (MEMO) study: a randomised controlled trial to evaluate the effectiveness of a physical activity program for pregnant women

    The MEMO study is a randomised controlled trial that will evaluate the effects of a physical activity intervention on short-term maternal and neonatal outcomes, as well as maternal physical activity levels at 6 months and 1 year postpartum. Women up to 18+6 weeks of gestation attending the Liverpool Hospital antenatal clinic will be recruited. The primary maternal outcome is the incidence of gestational diabetes mellitus (GDM) and the primary neonatal outcome is the incidence of macrosomia (>4000g). Secondary outcomes include: physical activity level (distance walked and number of steps taken weekly), percentage of participants with GDM requiring pharmacological treatment, gestational weight gain, incidence of labour induction, mode of delivery, incidence of third or fourth degree tears, incidence of pre-eclampsia, incidence of gestational hypertension, incidence of placental abruption, incidence of postpartum haemorrhage, HbA1c at 36/37 weeks in women with GDM. The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation. At 24-26 and 34-36 weeks of gestation, as well as 6 months and 1 year postpartum, maternal exercise habits and patterns will be assessed using a survey. Patient satisfaction will be assessed using the MEMO Study Patient Satisfaction Survey to be administered at 8-10 weeks postpartum.

  • Comparing a novel videolaryngoscope with the Macintosh in simulated difficult airway: a manikin study

    Airway or respiratory complication is one of leading causes of morbidity and mortality in anaesthesia. There are different techniques and intubating equipment (laryngoscope) available for anaesthetists to deal with difficult airways. Anaesthetists use their knowledge and previous experience to decide which type of laryngoscope to use in these cases. In this study, we are evaluating, for the first time, this newly available videolaryngoscope. It requires a technique called "indirect laryngoscopy". We are comparing it with the standard direct laryngoscopy by using the Macintosh blade. We hypothesise that In simulated difficult airways, the novel videolaryngoscope achieve a better laryngoscopy view as compared to the Macintosh blade. We will prospectively recruit 30 voluntary anaesthetic residents, registrars or consultants for this study. All participants will be tested on using each of the two intubation devices on a manikin with a simulated difficult airway. Participants will be assigned to one of the two groups – Group 1: novel videolaryngoscope followed by Macintosh laryngoscope, or Group 2: Macintosh laryngoscope followed by novel videolaryngoscope. The primary outcome is the best laryngoscopy view achieved. Secondary outcomes include: • The time taken for successful tracheal intubation. • Number of failed intubation. • Number of intubation attempts. • Number and type of intubating adjuncts used. • The ease of intubation, which will be surveyed using a visual analogue scale from 0-100mm.

  • Music Interventions for Dementia and Depression in Elderly care

    This project is investigating how music impacts levels of depression and symptoms of dementia in older people living in residential aged care facilities. It is part of larger international study involving European investigators. The project will study the impact of music on wellbeing for 500 older Australians living in residential care facilities in Australia over a 12-month period. Each facility participating in the study will be randomized into one of 4 groups (1. small music therapy group, 2. recreational group singing, 3. small music therapy group and recreational group singing, 4 standard care). Over the 12-month period, we will be collecting a range of data that will help us understand whether music has or has an effect on participants' mood, quality of life, and symptoms of dementia. Moreover, we will be asking care staff working with participants on a regular basis to complete questionnaires over the 12-month period, to help us understand the impact of the music intervention on caregivers' wellbeing and burden.

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