ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Informing extreme heat policy development in long distance running

    A lack of validation data exists that compares the response of exercising individuals in different heat illness risk rating categories proposed by publicly available extreme heat policies for sport and exercise. The project aims to validate and inform publicly available extreme heat policies for long distance running by observing the heat strain of runners exercising in environmental conditions that are graded as moderate, high, and extreme environmental risk ratings according to the policies. We hypothesise that a progressively graded and higher response in thermoregulatory (core temperature), cardiovascular (heart rate), and perceptual measures (thermal discomfort) will be observed when moving from moderate to high to extreme risk environments. We also hypothesise that the extreme risk rating category will be associated with the participants approaching a core temperature response that is typically deemed as a 'cut-off' for exercise.

  • The role of humidity upon the effect of post-exercise water dousing as a potential cooling intervention

    Water related recovery methods to treat hyperthermia (i.e. a highly elevated core temperature) are well understood, however dousing as a recovery method to reduce heat strain in contrasting humidities currently lacks experimental evidence. This study aims to build upon previous water dousing research by investigating the effect of water dousing upon the core temperature response following strenuous exercise in the heat under contrasting humidities. Based on theoretical data, we hypothesise that dousing in comparatively drier conditions will result in a greater decrease in thermal strain (core body temperature) compared to more humid conditions during recovery from exercise in the heat.

  • From the Ward to the Community: An Active Approach to Childhood Cancer

    This study will evaluate whether delivering an exercise program virtually to childhood cancer survivors who attend Camp Quality community programs is effective at increasing physical activity levels and improving self-efficacy. Who is it for? Children aged 5-18 years old, who have completed cancer treatment and are not currently participating in >60 minutes of moderate-vigorous physical activity daily will be recruited to participate. Study details The intervention involves a 12 week individualised exercise program prescribed over five sessions with an accredited exercise physiologist, within a framework that includes age-appropriate aerobic, resistance, balance and flexibility exercises at a moderate intensity. The control group will receive education about the current paediatric oncology exercise guidelines, however will be offered to participate in the intervention at the completion of the study. Participants will complete questionnaires and physical assessments at various timepoints throughout the study. It is hoped that findings from this study will help inform researchers about the efficacy of virtually delivering exercise interventions to childhood cancer survivors in the community setting.

  • Comparing doctor and patient attitudes towards advanced care planning in the Emergency Department

    Advanced care planning is an important aspect of care of the elderly population. The study plans to investigate how comfortable patients and doctors are discussing this in the Emergency Department and to establish patient awareness, pre-existing advanced care directives, who patients and doctors believe to be the best person to discuss this with and identify any barriers towards discussion in the Emergency Department. By identifying these patient and doctor perceptions, we can improve discussion of advanced care planning and overall patient care.

  • A Phase I Randomised, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect of Food on the Bioavailability of SKY-0515 in Healthy Volunteers and Patients with Huntington’s Disease

    This study is a first-in-human multi-center, Phase 1, randomised, double blind, placebo controlled study to evaluate the safety and tolerability of SKY-0515 in patients with Huntington’s Disease (HD). The study has 3 parts: Part C (i) a non-interventional observational arm and Part C (ii) where two dose levels (3mg and 9mg) will to be evaluated in HD patients and Part C (ii) Extension where two levels (9mg and 4mg) will be evaluated in HD patients. Part C (i): Participants will be required to attend 2 clinic visits over a period of 28 days. Health information and blood samples will be collected at these 2 visits. No treatment is given in this part of the study. Upto 50 participants will be enrolled. Following completion of Part C [i], participants will be invited to participate in the treatment portion of the study - Part C [ii], based on eligibility. Part C (ii): Enrolled HD patients will be randomised to 3 parallel treatment arms to receive 3mg study drug ,9mg study drug or placebo for a period of 1 to 3 treatment cycles (each cycle is 28days). Part C (ii) Extension: Enrolled HD patients who completed the last treatment visit in Part C(ii) will be offered to enter an Extension study for Part C(ii) and will be randomised to 3 treatment arms to receive 9 mg study drug (1st arm) 9 mg or 4 mg study drug (2nd and 3rd arms)

  • Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT)

    To assess the Tolerability and Safety of inhaled CMS and the profile while, comparing once daily (QD) with twice daily (BID) Administration for 28 days, The study will be measured by safety and respiratory tolerability events.

  • Low-Intensity Transcranial Focused Ultrasound for the Treatment of Obsessive-Compulsive Disorder

    This study aims to assess the safety and potential effectiveness of low-intensity transcranial focused ultrasound for the treatment of obsessive-compulsive disorder. You may be eligible for this study if you are aged between 18 and 50 years and you have been diagnosed with moderate to severe Obsessive-Compulsive Disorder (OCD) for more than 12 months. Transcranial ultrasound stimulation (TUS) will be delivered via the NeuroFUS system. This uses focused ultrasound sonication, delivered to the scalp, to stimulate neural activity in cortical and subcortical regions of the brain. In total, participants will receive six sessions of stimulation [80 second stimulation sessions of theta burst patterned TUS], delivered to two brain regions for three sessions each in the resting state, and during a symptom-inducing task. The duration of the participant participation is 10 week plus 4 weeks follow-up.

  • Mindfulness and personality in the general population

    Generally, practicing mindfulness has been found helpful for positive and negative affect in the general population. However, it is as of yet unclear what the most effective dose of mindfulness practice is, and how this differs across individuals and personality types. This study seeks to determine whether some individuals (based on personality) find different lengths of a mindfulness practice more helpful than others. In this study, the impact on positive and negative affect of two different lengths of mindfulness practice (and a no-practice control group) are compared across personality types. Data will be collected online from an adult general population sample, building on an approach that has proven feasible in the Principal Investigator’s previously published research. The current study should help future mindfulness-based programs to better personalize the mindfulness practices they offer, resulting in better outcomes for their participants.

  • Bridging the gap in physical activity and diet support for breast cancer survivors in Australia: a randomised controlled trial in primary care

    The purpose of this study is to test if receiving supportive text message program called EMPOWER-SMS GP can help improve breast cancer survivors’ physical activity and other health outcomes compared to not receiving any messages. We also want to know the barriers and enablers to implementing this program into general practices compared to hospitals or other recruitment strategies (e.g. social media, poster, email, e-newsletter, cancer networks) based on feedback from participants and general practice staff members. Who is it for? You may be eligible for this study if you were diagnosed with breast cancer, finished surgery, chemotherapy and/or radiation therapy within the past 3 years, have a mobile phone and attended =1 general practice appointment within 2 years. Study details Participants in this study will be randomised (50/50 chance) into two groups. One group will receive four text messages per week at random times and days in addition to their usual care for 6 months. The other group will receive usual care alone for the 6-month period, and will be offered the text message program after that time. All participants will complete number of questionnaires at the start of the study and again at 6-, 12-, 18- and 24*- months (*if funding and time allow). It is hoped EMPOWER-SMS GP will help breast cancer survivors’ feel better after treatment, will be easily integrated into general practice workflows and will be acceptable and useful for participants and general practice staff members.

  • Clinical study assessing the preliminary efficacy and safety of RXC004, in Patients with Advanced Pancreatic Cancer that have Progressed following Therapy with Current Standard of Care

    This study will assess the anti-cancer activity of RXC004 given alone in participants with advanced pancreatic cancer whose cancer has worsened following therapy with current standard of care. You may be eligible for this study if you are participating in the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437) and have RNF43-positive pancreatic ductal adenocarcinoma that has progressed following therapy with current standard of care. All participants will be treated with RXC004. RXC004 capsule strengths are 0.5 mg and 1.0 mg capsules to be taken at a dose of 2mg daily, taken orally and fasted. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. It is hoped that this study will help increase treatment options for patients with advanced pancreatic cancer.

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