ANZCTR search results

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

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30801 results sorted by trial registration date.
  • Evaluation of an online program for youth anxiety.

    It is well documented that rates of drop out from youth digital mental health programs are high, with on average only half of modules being completed. Greater adherence and engagement with programs has been found to be associated with better outcomes. Finding ways to encourage greater program completion may enhance the benefits that users derive. The current study aims to assess the effectiveness of an imagery-based motivation enhancement component embedded within an online program for youth anxiety. The study examines whether the motivational component improves young people’s engagement with the platform, and the subsequent effect on outcomes following treatment.

  • A Phase 1 Study of AP02 (Nintedanib Solution for Inhalation) Delivered via the PARI eFlow® Nebulizer System to Evaluate the Safety, Tolerability, and Pharmacokinetics of AP02 in Healthy Volunteers (AP02-002)

    This is a placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of multiple dose levels of AP02 (Nintedanib Solution for Inhalation) administered using the eFlow Nebulizer in healthy volunteers, The purpose of this study is to learn about the study drug properties and determine what doses of AP02 are safe and well-tolerated in humans. AP02 is a liquid solution that is inhaled into the lungs with a device known as a nebuliser (the eFlow Nebulizer). The nebuliser releases the liquid as tiny particles a person can breathe in through their mouth to directly target the lung tissue, which is the primary disease site.

  • Clearview-BC: A phase 1 Positron Emission Tomography (PET) - Computed Tomography (CT) study to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 in patients with Bladder Cancer

    This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with metastatic bladder cancer. Who is it for? You may be eligible for this study if you are an adult with recurrent, histologically proven bladder cancer with a macroscopically visible tumour on diagnostic imaging. Study Details All participants who meet the eligibility criteria in this study will receive a single dose of 89Zr-hu/mo-10D7 as an intravenous infusion over 30 minutes to delivery maximum dose of 4.5 mg protein and 37 MBq radiation. During and after completion of the treatment participants will be assessed for safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 via vital signs, blood tests, ECG, urinalysis and PET/CT scan. It is hoped that this research project will demonstrate hu/mo-10D7 targets bladder cancer metastases in humans and therefore prove its potential utility as a theranostic in ovarian cancer.

  • Exploring impacts of a codesigned program mapping physical activities to personalised goals for children with autism

    Physical activity (PA) improves motor skills, fitness, social functioning, muscular strength, and endurance in children with autism. However, the benefits of PA depend on the type of PA. In this study, we will co-design a PA program with parents and children to tailor benefits of PA to individual goals and determine the impact the PA has on everyday life. We expect to find that parents and children share some common goals for PA; that fun-based individual activities will be preferred PA; and that positive physical and mental health outcomes will result from adherence to the PA program.

  • Stomach Electrical Activity Following Oesophageal Cancer Surgery

    This study investigates the characteristic electrical activity of the stomach conduit in patients with delayed gastric conduit emptying (DGCE), a clinical condition characterised by persistent nausea and difficulty swallowing after oesophageal cancer surgery. Who is it for? You may be eligible for this study if you are an adult male or female who has previous has had oesophageal cancer surgery at Peter MacCallum Cancer Centre atleast 12 months ago. Study details All participants will undergo a series of patient questionnaires regarding their symptoms, followed by a 4-hour gastric motility assessment using the device known as 'Gastric Alimetry', which works similarly to an ECG for the stomach. This will facilitate the identification of electrical activity characteristics for DGCE and validate the role of Alimetry in diagnosing DGCE.

  • Tai Chi Stress Reduction Program for University/College Students

    This study assesses whether a Tai Chi-based stress reduction program, including two educational workshops on stress management and healthy lifestyle and 8-week Tai Chi, can reduce the stress, anxiety, and depression levels among university students. Participants will be randomly assigned to either the Tai Chi program or a waitlist control group, 20 in each group. We hypothesize that those in the Tai Chi group will report lower stress levels and enhanced overall health compared to the control group. Questionnaires and other vital measures will be tested at baseline and 8 weeks. We will also perform interviews with participants in the beginning and at the end of this study to understand their expectation and satisfaction towards this stress reduction program.

  • The effects of a single bout of exercise and chronic training program on cancer cells in breast cancer survivors

    The aim of this project is to explore the effects of an acute bout of exercise (before and after a training intervention) and the chronic effects of a 12-week resistance vs aerobic training program on acute and resting expression of signalling proteins, known as myokines, and their cancer-suppressive effects, in relation to body composition, in breast cancer survivors. Who is it for? You may be eligible for this study if you are a woman with stage I-III breast cancer who has completed primary treatment at least 4 months prior to commencing this trial, and have been medically cleared for exercise. Study details Participants will be randomly allocated to a 12-week exercise program involving either resistance or aerobic training. In the weeks immediately before and after the 12-week program, participants will also complete an acute bout of exercise. Participants will be asked to provide blood and complete questionnaires and physical testing before and after the acute bouts of exercise and 12-week program. It is hoped that findings from this study shed light into the mechanisms behind exercise's effect on breast cancer management.

  • Administrative intervention to support testing after gestational diabetes and hypertensive disorders in pregnancy

    Women who have a diagnosis of gestational diabetes or hypertension in pregnancy are recommended to have further testing postpartum to review their longer term health risks; however, many women do not undergo testing in a timely manner due to many competing priorities. This study is evaluating whether an intervention providing administrative assistance can improve attendance and testing in the post partum period. Participants in the POST-IT study are randomly allocated to receive standard of care (usual advice with no administrative assistance) or intervention (assistance to book GP visit and recommended testing after GDM or HDP). Attendance rates, uptake of testing, and acceptability of the intervention will be evaluated at four months' postpartum via telephone survey.

  • Implementation and effectiveness of the Connect for Relative/Kinship Carers program

    The goals of this research project are to evaluate the implementation and effectiveness of an attachment-based and trauma-informed intervention for relative/kinship caregivers. The program is delivered in group format across 9 weekly 1.5 hr sessions and introduces caregivers to a set of attachment-informed principles relating to sensitive caregiving, child and youth development and family wellbeing. Overall, the program aims to reduce caregiver strain and promote caregivers' understanding of and sensitive responding to their child's attachment needs, and, in turn, strengthen the quality of the caregiver-child relationship and promote children's behavioural and socio-emotional wellbeing.

  • Can a pharmacist-led education and support intervention assist patients to reduce their glucocorticoid (steroid) dose and improve outcomes for patients with rheumatic diseases?

    Glucocorticoids (GCs, also known as steroids or prednisolone) are often used to treat rheumatic diseases such as Rheumatoid Arthritis (RA), Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA), While they can relieve symptoms, they are also associated with many side effects including reduced life expectancy, infection, weight gain, hypertension, diabetes, osteoporosis, cataracts, mood disturbance, thin skin, and easy bruising. In recognition of this, Australian Living Guidelines for RA recommend against the long-term use of GCs. However, studies have shown that once GCs are started, they are often difficult to stop even when the joint disease of RA appears to be well-controlled. Reducing and stopping GCs is often difficult to achieve in the clinic setting, where there are insufficient resources to provide comprehensive education and support. There are no proven methods to improve implementation of these recommendations. The aim of this study is to develop a pharmacist-led GC intervention to assist with GC reduction and cessation and minimise the side effects associated with GC use in patients with rheumatic diseases compared to “usual care”. Rheumatologists will refer people with RA, PMR and GCA who require gradual reduction of GC dose and/or cessation. Patients will either receive the new pharmacist-led intervention or receive “usual care” in an existing routine clinic plus a written schedule for reducing the GC dose from the pharmacist. Patients in the new intervention arm will receive 4-weekly telehealth appointments or phone calls when the pharmacist will collect patient reported data on dose, side effects, and barriers to dose reduction. All participants will have face-to-face visits at baseline, 6 months, and 12 months, when additional information including height, weight, BMI, blood pressure, disease activity and relapse will be collected. The aim will be to see if the pharmacist-led intervention increases the likelihood of achieving the target GC dose at 6 months and reduces the overall GC dose, relapses/flares, side effects, ED presentations and hospitalisations.

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