ANZCTR search results

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

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33055 results sorted by trial registration date.
  • KONTAKT a Social Skills Group Training Intervention for Teenagers with Autism Spectrum Disorders in Australia

    Adolescents diagnosed with ASD experience persisting deficits in social communication and social interaction across multiple contexts. Contrary to popular belief many children with ASD have insight into their impairments and accurately perceive their social and communication abilities. They experience high levels of social anxiety, loneliness and isolation, despite a strong desire for friends. It is likely that many of these adolescents have much to gain from social skills training. KONTAKT is a manualized Social Skills Training Group (SSTG) program designed for children and adolescents with ASD which aims to improve communication, social interaction skills, reduce the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting. A large randomized controlled trial in Sweden found that adolescents who participated in KONTAKT demonstrated improvements in social skills, behaviour, reduced stress and improved overall functioning as reported by parents immediately following and at three months after the program. However, social skills are at least in part influenced by social cultural contexts and there is a need to understand the feasibility, acceptability and effectiveness of KONTAKT in an Australian context. The aim of the current project is to develop and evaluate the effectiveness of a social skills group training intervention, KONTAKT, for Australian adolescents with ASD. In meeting this overall aim this research will be conducted in four phases, commencing with a needs assessment. Phase two will involve the translation and modification of the original KONTAKT manual, and child and parent workbooks from Swedish to Australian English and to the Australian context, inclusive of appropriate homework. Following pilot testing, evaluating the clinical feasibility and acceptability of KONTAKT Australia, phase four will examine the efficacy of the KONTAKT Australia in a two armed randomized controlled trial in a sample of adolescents with ASD.

  • To determine whether androgen deprivation therapy or androgen blockage therapy upregulates receptor activity of Gallium68 Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans for men with castrate resistant prostate cancer.

    This study will investigate the use of Gallium 68 Prostate Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans in the treatment of metastatic prostate cancer. Who is it for? You may be eligible to join this study if you are Male, aged 18 years or above, have a pathologically confirmed adenocarcinoma of the prostate that has metastasised. Study details There are two cohorts under investigation: one group who have castrate sensitive metastatic prostate cancer commencing androgen deprivation therapy for clinical reasons while the other has castrate resistant metastatic prostate cancer, who are commencing androgen blockage therapy (Abiraterone or Enzalutamide) for clinical reasons. Participants will receive a GaPSMA PET scan, free of charge. If the GaPSMA PET scan detects any cancer, the participant will continue with study. If the GaPSMA PET scan does not detect any cancer, then the participant is withdrawn from the study. Irrespective of whether or not the GaPSMA PET scan detects any cancer, the participant will receive clinical treatment as indicated. The eligible participant will return for follow-up PSMA PET scans at days 9, 18 and 28. The participant will continue with ADT as clinically required. Clinical information and imaging results will be collected at these times points (baseline, Days 9, 18 and 28). The findings of the study will enable clinicians to better plan for the treatment of metastatic prostate cancer, particularly with the use of treatment that target PSMA cancer sites.

  • Comparing Pre-prostatectomy and Post-prostatectomy Exercise Intervention for Prostate Cancer Patients.

    This study aims to evaluate the effectiveness of a 6- week comprehensive supervised pre-surgical exercise program in prostate cancer patients scheduled for prostatectomy. Who is it for? You may be eligible to join this study if you are a male aged between 45 and 80 years of age and have been diagnosed with localised prostate cancer with at least seven weeks to until scheduled surgery date. Study details Study participants will be allocated by chance to one of the two groups. First group will receive a 6- week comprehensive supervised pre-surgical exercise program consisting of progressive resistance and aerobic exercise. Second group will receive usual care during the pre-surgery period along with information on performing exercises on the trunk stabilising muscles similar to the exercise intervention. This group will be provided an option to partake in the exercise intervention at completion of 6 weeks post-surgery assessments. Testing will be conducted at baseline, pre-surgery, 6 weeks post- surgery (6PS), and 12 weeks post-surgery (12PS). In addition, a 24-hr pad test will be undertaken after discharge from hospital. This research is a critical step in a series of studies required to determine the most effective and efficient ways to maximize prostate cancer patient health and therefore lay the foundation for future research.

  • Profiling the acute post-exercise biochemical environment in trained athletes

    Exercise is well known to induce multiple physical and psychological benefits, although the nature of these benefits is dependent on the type of exercise performed. For instance, resistance training can increase muscle strength and mass, while endurance exercise can enhance the ability and efficiency to use energy so that exercise can be performed at higher intensities or longer durations. During and immediately after exercise, a multitude of factors are released from skeletal muscle into the circulating blood. These exercise released biochemical components are termed ‘exerkines’. The presence of exerkines after exercise has been shown to be determined by the mode of exercise (i.e., resistance versus endurance). Whether exercise training can modulate the resting and post-exercise profile of exerkines has yet to be determined. Furthermore, no studies to date have investigated the effect of the acute post-exercise exerkine response on the ability of muscle to recovery and repair following itself. Thus, the aims of this study are to: 1. Characterize the exerkine expression profile present in serum of well-trained endurance athletes, strength athletes, and untrained individuals at rest and post-exercise. 2. Investigate the effect of resting serum from healthy untrained and trained individuals on muscle cell recovery and repair processes in vitro.

  • An investigation into heterozygosity for glycogen storage disease as a possible cause of glycogenic hepatopathy in type 1 diabetes

    Glycogenic hepatopathy is an uncommon condition causing painful liver enlargement, impaired liver function and in the long term, may cause irreversible liver fibrosis in young individuals with type 1 diabetes. We wish to study whether there may be an underlying genetic cause which increases the risk for people to develop this condition. Glycogenic hepatopathy is thought to occur when there are concomitant high blood glucose levels and elevated insulin levels, and may be associated with elevated serum lactate levels. This triad contributes to increased liver glycogen storage ultimately culminating in liver damage. Excess hepatic glycogen storage is also characterstic of glycogen storage diseases, which are a group of heritable conditions where storage of glucose or release of glucose from storage does not occur normally, and can cause enlargement of the liver similar to glycogenic hepatopathy. People who have glycogen storage diseases typically have a mutation (change) in both copies of the causative gene. However, we are addressing the question of whether having type 1 diabetes with only one copy of the mutation for glycogen storage diseases (heterozygosity) is sufficient to precipitate abnormal glucose storage or release, resulting in the development of glycogenic hepatopathy. In support of our hypothesis, strict blood glucose control reverses glycogenic hepatopathy. This pilot study will help clarify whether genetic sequencing for mutations which cause glycogen storage disorders can identify young people with type 1 diabetes at risk of glycogenic hepatopathy. This will enable us to alter clinical practice by facilitating genetic counselling of these patients on the particular importance of tight blood glucose control in their case and make diagnosis of this disorder less invasive. Indeed, currently, a definitive diagnosis of glycogenic hepatopathy can only be made by liver biopsy. This may be hazardous particularly in young children, a common time when the disorder first presents. Determining whether there is a genetic mutation associated with glycogenic hepatopathy may enable diagnosis to be made without having to perform a liver biopsy.

  • Impact of wearable activity tracker usage on participant step counts in a large scale, mobile health (mHealth) intervention.

    Wearable activity trackers are increasingly being utilised by consumers in daily life. It is unknown if use of these more sophisticated devices leads to improved physical activity outcomes. The aim of the current study is to evaluate physical activity outcomes in healthy adults undertaking a health and lifestyle challenge called the Stepathlon, which is a 100-day event undertaken by adult employees in workplaces around the world. In the current study, a propensity score weighted analysis approach will be used to compare physical activity outcomes in users of wearable trackers compared to participants in Stepathlon who do not use one of these trackers, and instead choose to use a pedometer, which is an older technology.

  • Self-administered acupressure for the management of allergic rhinitis

    This randomised controlled trial aims to investigate the efficacy and safety of self-administered acupressure for the management of allergic rhinitis. Acupressure is a subtype of acupuncture without needle insertion. It applies fingers to press points on the body. The study consists of 1-week run-in, 4-week treatment and 4-week follow-up period.

  • Effects of endurance training on muscle adaptations in males.

    The project aims to investigate the effects of different types of endurance exercise typically performed by endurance athletes on changes in mitochondria (note: Mitochondria are our muscles’ “power houses”, producing the energy required to enable your muscles to contract). This will allow us to understand what type of endurance exercise increases the mitochondrial reticulum (network of interconnected mitochondria) and what type of exercise stimulates a higher quality control (recycling of mitochondria). The information obtained from this research has implications for both performance and health, as it will allow better prescribe exercise and to best promote mitochondrial adaptations.

  • Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson’s Disease

    This study aims to see whether using melatonin assists with sleeping in patients with Parkinson’s Disease.IMET stands for Individual Medication Effectiveness Tests. An IMET is a new way of working out whether the medication is working for the individual taking the medicine. Most projects that test the effectiveness of medicines give information about the effects of that medication on groups of people. IMETs give information about the effectiveness of the medicine only for the person doing the test. The IMET will take twelve weeks, and use active and placebo (inactive) medication. Placebo and active medication look exactly the same, but the placebo is not active and has no effect. The IMET team will arrange things so that neither you nor your study doctor, will know what medication you will be taking at any one time. But everyone will know that you will be taking either medication for periods of two weeks at a time, and in a random order.

  • Health Technology Assessment of the Clarity Autoscan system: Motion correction and margin reduction in the radiation therapy treatment of prostate cancer

    The primary purpose of this trial is to evaluate the safety, clinical outcomes, patient preferences and economic benefits of reduced margins for radiation therapy for prostate cancer, with the use of the Clarity Autoscan ultrasound system. Who is it for? You may be eligible to participate in this trial if you are aged 50 or over and have been diagnosed with prostate cancer, for which you are scheduled to commence radiation therapy treatment. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either a reduced margin around the prostate during radiation therapy of 3-5mm, or to receive the standard margin of 7-10mm. All patients, regardless of allocation will have fiducial markers inserted prior to commencement of treatment, and will have the Clarity Autoscan ultrasound monitoring prostate motion throughout treatment, increasing the accuracy of treatment. The allocated treatment protocol will continue for all radiation therapy treatment sessions (up to 39). Researchers will ask participants for their preference regarding monitoring during radiotherapy, and the acceptability of the Clarity Autoscan system. Participants will also be followed up for up to five years post treatment to assess side effects and for one year to evaluate the cost-effectiveness of the motion monitoring. It is hoped that the findings from this trial can be used to inform a health technology assessment reviewing the safety, efficacy and cost-efficacy of reduced margins during radiotherapy for prostate cancer using the Clarity Autoscan system.

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