ANZCTR search results

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

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32707 results sorted by trial registration date.
  • An almond, dried grape and dried cranberry (AGC) mix for improving endurance exercise performance in athletes

    The main aim of this study is to assess whether consuming a mix of almonds, dried grapes and dried cranberries daily for four weeks can improve recovery from fatigue and exercise performance compared with a control snack. The secondary aims are to investigate the relationship between consumption of these foods and blood and urinary markers of training-induced stress/damage and choice reaction time at rest and during exercise. Additionally, this study aims to evaluate the whether changes in heart rate can be used to predict changes in endurance exercise performance. Almonds are a rich source of arginine and antioxidants, while grapes and cranberries are also rich sources of antioxidants and nitrates. Studies have shown that dietary antioxidants improve endurance exercise performance by reducing exercise-induced damage to muscle. In addition, an increased dietary intake of arginine, nitrates and nitrites has been shown to improve endurance exercise performance in recreational athletes due to increases in blood flow to muscles. Thus, combining almonds, which are a good source of antioxidants and arginine, with grapes and cranberries, which are good sources of antioxidants and nitrates, may reduce exercise-induced damage to contracting muscle and promote increased muscle and brain blood flow. This in turn might reduce fatigue and promote improvements in endurance exercise performance. The period of heavy training is designed to produce negative changes in all of the outcomes discussed above, thus it is desirable for AGC to reduce the magnitude of these negative changes, in addition to resulting in superior changes in the outcomes following the taper training, when measures should be at their peak values.

  • how best to treat insomnia:comparing cognitive therapy with mindfulness

    the study sought to determine whether Cognitive Therapy or Mindfulness-based therapy better assists participants with primary insomnia. Participants were allocated to each treatment or a wait-list control. Those in the wait-list were allocated to an active treatment after the wait-list period. Outcome measures included quality of sleep and amount of time asleep.

  • Vitamin D and falls in people with stroke

    This project is a world first and vital step towards developing an effective falls prevention intervention for the large numbers of Australian stroke survivors. Fifty people aged over 50 years old with a diagnosis of first ever stroke will be recruited and monitored for 12 months for falls, falls injury, serum levels of vitamin D, parathyroid hormone, highly sensitive C-reactive protein and triglycerides, and strength, balance and walking in people after stroke. This project will produce detailed information and understanding about the link between vitamin D and falls in stroke survivors, an essential step in enabling the development and evaluation of effective falls prevention interventions (e.g. Vitamin D supplementation) for stroke survivors. The outcomes will enable clinicians and researchers to develop evidence-based interventions that will be implemented and tested in future projects in order to reduce falls and falls injury in older people after stroke and to improve their quality of life. The data produced by this project will mean that future phases of this work will attract government and other funding, such as National Health and Medical Research Funding. Overall impact will be measured by the development of a successful intervention that reduces falls in people with stroke. Aims 1. Describe the trajectory of vitamin D levels in people in the first twelve months after stroke. 2. Describe the relationship between vitamin D levels, physical function (strength and balance), falls and injury in people in the twelve months after stroke. 3. Determine the relationship between other related biochemical markers (parathyroid hormone, C reactive protein and triglycerides) and falls in the twelve months after stroke. Research Questions: 1. What is the trajectory of vitamin D levels in the first 12 months after stroke? 2. What is the current use of vitamin D supplementation in first 12 months after stroke? 3. Is vitamin D deficiency associated with physical function and falls in the twelve months following stroke? 4. Is vitamin D deficiency associated with injury severity following a fall in the twelve months after a stroke? 5. What is the relationship between other biochemical markers (parathyroid hormone, highly sensitive C-reactive protein and triglycerides) and falls in stroke survivors in the first twelve months?

  • Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 5 substudy 10: Eribulin

    This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. The purpose of this is to investigate whether gene or CD31 protein profiles may be used to select the best treatment for participants with advanced cancer. Who is it for? You may be eligible for this study if you are over 18 years old and have CD31 positive advanced and/or metastatic angiosarcoma OR have CD31 positive advanced and/or metastatic sarcomas. Study details All participants will be given eribulin via intravenous administration on Day 1 and Day 8 of a 21 day cycle. Participants will continue to be given the medication in 21 day cycles until the disease has progressed or there are adverse reactions that are not tolerated or the participant withdraws for any reason. Participants will undergo assessments at 6 weekly intervals or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will also be assessed via clinical assessment, blood tests and questionnaires prior to each treatment with eribulin. It is hoped that this study will help increase treatment options for participants with advanced metastatic cancer. We cannot guarantee that participants will receive any benefits from this study.

  • A phase II randomised controlled trial to establish if LEE0011 (ribociclib) is effective in inhibiting the growth of prostate cancer cells.

    This study aims to examine the effect of a medication called Ribociclib on human prostate cancer Who is it for? You may be eligible for this study if you are older than 18 years and have localised prostate cancer with a planned radical prostatectomy. Study details After the Protocol version 4.0 amendment implementation in August 2022, randomisation to the control group is stopped. All subsequent participants will be recruited to the experimental group. All new Participants post protocol version 4.0 implementation will be assigned to take a tablet of the study medication (in addition to the usual care) for the 21 days leading up to their prostatectomy. At each study visit participants will have various assessments such as blood testing, urine testing, scans, and questionnaire completion. A sample of prostate tissue will also taken during surgery. It is hoped this research will help demonstrate the activity of this medication against prostate cancers, and lay the groundwork for more trials using this drug.

  • Active Recovery in Rehabilitation Environments: A descriptive study of patient activity in inpatient rehabilitation units.

    Current best clinical practice for people in inpatient rehabilitation aims to increase physical, cognitive, and social stimulation for patients to promote recovery. The rehabilitation environment, that is, the physical building including the design and facilities/equipment available, and the models of care, potentially impact on people in rehabilitation’s engagement in activities that may potentially contribute to their recovery. This prospective observational study will examine the impact (if any) on patients’ levels of activity that may occur due to a change in physical environment and services when existing rehabilitation services are merged and will in the future be provided in a new rehabilitation facility. Data will be collected at two time points with different patient populations - 2018 at the existing inpatient rehabilitation services at The Canberra Hospital/Calvary Public Hospital and 2019 at the new rehabilitation facility University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research. This study aims to comprehensively describe the behaviour and activity of inpatients in these rehabilitation units so as to determine how much of the patient’s day is spent in activities that have the potential to contribute to their recovery, and how this may differ (if at all) between the rehabilitation units. Activity types and amounts will be determined through observation using behavioural mapping and accelerometers to measure the physical, cognitive and social activity of patients in patients receiving rehabilitation in inpatient rehabilitation units before and after the move. This research provides a unique opportunity to increase understanding of the potential impact, if any, of building design and models of care on patient activity within rehabilitation units and contribute towards future health service design.

  • A study to evaluate the Safety and Pharmacokinetics (Pharmacokintecus, the measure of how the human body processes a substance) of ETX0282 when administered orally to healthy participants.

    This research project is being conducted to investigate the safety, tolerability, and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Dose of oral ETX0282 when administered alone and in combination with Cefpodoxime Proxetil in healthy adult subjects.

  • Get Healthy! A pilot program to support people with intellectual disability to stay active and eat well

    The 'Get Healthy!' program is a 12-week physical activity and nutrition intervention. It has been designed to encourage healthy lifestyle change for adults with intellectual disability. The goal of this pilot study is to assess the feasibility and impact of this program for participants with intellectual disability. The results of this study will be used to refine the "Get Healthy!" program for future use. The primary aim of the intervention is to assess the feasibility of implementing the 'Get Healthy! Physical Activity and Nutrition Program' with adults with intellectual disability. Secondary intervention aims are to determine what, if any, pre-post program changes occur across the following outcome measures: • Body Mass Index • Waist circumference • Cardiovascular fitness • Physical activity (amount and intensity) and sedentary behaviours • Blood pressure • Physical strength • Dietary intake (energy intake, food group consumption and diet quality) • Dietary and physical activity knowledge • Quality of life

  • Discovering the sense of touch- somatosensory discrimination training for children with cerebral palsy

    Following our feasibility pilot, Sense© training was modified to increase suitability for a paediatric population of children with HCP. The principles of training remain the same and children progress through the same levels of graded somatosensory training as adults. To facilitate child engagement with the Sense© training, the principles of self-determination theory and family centred service were incorporated into the provision of Sense© for Kids training. To improve the relevance of Sense© for Kids training to children with HCP and their families further modifications were implemented following consumer engagement. Focus groups and interviews were conducted and feedback from children and their families were integrated into changes to Sense© for Kids training. A consumer representative also vetted all aspects of the study protocol and details of the intervention. These changes are aimed at reducing the scheduling demands on families and increasing the education provided to parents. Parent coaching will be used to facilitate maximal carryover of the benefits of therapy into everyday life following the completion of the formal intervention period. Our pilot work suggests that children improve in trained somatosensory domains, motor performance, and in trained occupational tasks. A qualitative investigation of parent and child engagement suggests that improvements were also observed in untrained tasks requiring bimanual function. Improvements following Sense© training were maintained six months after training ceased and warrant further investigation with a larger sample. In order to test the efficacy of the Sense© for Kids training, a “best practice” comparison intervention will be used to provide adequate control for ‘dosage’ and maintain the external validity of this trial. Further, it is considered unethical to withhold potentially effective interventions in controlled comparison conditions. Goal Directed Training delivered via Home Program is an evidence based intervention with a green light on the traffic light system of evidence for children with HCP. Because there are no evidence based somatosensory discrimination interventions for comparison, Goal Directed Training via Home Program will act as our control. Goal Directed Training is a motor learning approach which uses a child’s goals to allow problem solving and indirectly elicit movements needed to complete a task but does not include any direct somatosensory training: it is therefore a ‘best practice’ control intervention incorporating common features of Sense© for Kids training but no direct somatosensory training. Our primary objective is to determine whether Sense© for Kids training, a somatosensory discrimination intervention, is more effective than placebo (Goal Directed Training via Home Programs) in improving somatosensory discrimination in children with HCP.

  • A Healthy Online Professional Program for Early Learners (HOPPEL) targeting educators in Early Childhood Education Care addressing physical activity and nutrition behaviours of young children

    Purpose The aim of this study is to evaluate the feasibility, acceptability and potential efficacy of a Technology-Mediated Professional Learning (TMPL) package delivered to Early Childhood Education and Care settings (ECECs) within one orgnisation in Tasmania. Hypotheses ECEC services where educators have participated in a TMPL programme will have better quality nutrition and physical activity environments and children who attend these services will participate in higher levels of physical activity compared with educators and children who attend services that have not participated in a TMPL programme

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