ANZCTR search results

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

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31326 results sorted by trial registration date.
  • A randomised controlled trial and consumer characteristics of the Stress eHealth wellbeing program.

    This project will involve trialling a multi-component online stress reduction program (Stress eHealth) designed to reduce stress and anxiety and improve mental and physical wellbeing. Those that consent will be randomly allocated to the Stress eHealth program (immediate access group) or a wait control group (delayed access group). The delayed access group will receive the intervention following a 10-week waiting period. Participants randomised to the Stress eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Weeks 1-5) assessment, post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18). Participants randomised to the delayed access group will complete the same assessment phases, except for the 3 month follow-up assessment, as they will be given access to Stress eHealth program following the 1 month follow-up assessment (Week 10). However the delayed access group will be asked to complete the post intervention assessment after they complete the Stress eHealth program (Week 16).

  • Intravitreal Aflibercept for the Treatment of Treatment Resistant Diabetic Macular Oedema

    This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for DMO and have persisting DMO despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health-related quality of life (HRQoL) among these patients.

  • A randomised controlled trial of an online healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE)

    The aim of the I-DECIDE trial is to evaluate an online healthy relationship tool and safety decision aid for women experiencing domestic violence. The study will investigate whether the I-DECIDE intervention can be effectively delivered online, and whether it can overcome some of the barriers encountered in face-to-face interventions. The intervention is designed to provide tailored information, resources, and feedback that enables women to self-inform, self-reflect, and self-manage. It is hypothesised that using I-DECIDE could increase women's self-efficacy and reduce their depressive symptoms when compared to a standard website. Secondarily, it is anticipated that I-DECIDE could increase the number of actions for safety and wellbeing that women engage in and reduce their level of fear while remaining cost-effective.

  • Monitoring biopsychosocial (BPS) health and wellbeing indices through wearable sensor devices and affective (emotions and mood) mobile app: The development of predictive algorithms to better understand and improve health.

    The aim of this project is to explore the relationship between different emotional states and physical changes in the body such as heart rate, skin temperature, movement levels. Being able to track emotional changes (e.g. anxiety, calmness) within each day along with physical changes (e.g., increased heart rate) will help us to better understand trigger points for health symptoms. With a large amount of emotional and physical data we will be able to begin to identify predictors of changes to well-being, as well as to develop profiles of when someone is beginning to experience a drop in well-being, for example, becoming stressed or anxious.

  • A Phase I, Single-center, Open-label Fixed-sequence Study to Assess the Effects of PRN1008 on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Adults

    This will be a single center, open-label, fixed-sequence study to investigate the effects of a single dose of PRN1008 on the PK of midazolam, a CYP3A4 substrate, in healthy participants. One cohort of 12 participants will be studied.

  • Examining the Feasibility of an Internet-Delivered Cognitive Behaviour Therapy program for emotional wellbeing among people with epilepsy.

    The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity Cognitive Behaviour Therapy (CBT)-based self-management program, the Managing Your Wellbeing Epilepsy Course, in reducing symptoms of anxiety, depression and disability among adults with epilepsy. The Course contains a 5-lesson 8 week CBT program, which can be administered via the internet. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. We expect participants will rate the Course as acceptable and will report that it was worth their time. We also expect that overall sample will make improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment, which will be maintained at 3-month.

  • A Study to Assess the effect of once-daily Subcutaneous APL-2 in Healthy Adult Subjects

    APL-2 is an experimental drug being developed by Apellis Pharmaceuticals Inc for the potential use as a treatment for people with a broad range of blood disorders (including paroxysmal nocturnal hemoglobinuria (PNH)) and certain types of auto-immune diseases). PNH is caused by a small change to the individual’s genes, which results in red blood cells being broken down prematurely. People with PNH typically feel tired and often see some blood in their urine. The condition is unfortunately progressive with sufferers needing increasing medical care, with an average life expectancy of only 10 years after diagnosis. The currently available treatments are insufficient to deal with this complex disease with most patients not fully responding to the treatments. APL-2 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent the breakdown of red blood cells and keep them healthy. It is hoped that APL-2 will help improve the quality of life and reduce the severity of the condition for PNH sufferers. In this study, multiple ascending doses of APL 2 will be assessed in healthy volunteers. The assessments of the safety, tolerability, pharmacokinetics, and pharmacodynamics following administration of single doses of APL-2 will guide decisions to further develop the drug.

  • The effect of flavonoids from cherries on memory and cognition in older adults with mild to moderate dementia

    This study aims to assess whether further cognitive decline can be delayed or prevented in people with mild to moderate dementia through the consumption of flavonoids in cherry juice over 12 weeks. Secondary outcomes included anti-inflammatory effects, changes in functional and physical ability and depressive symptomatology.

  • Know and Grow: An investigation into parent and family involvement in eating disorder treatment.

    The study aims to explore the impact of parent skills training on outcomes of children and families experiencing eating disorders. It is hypothesised that children whoses parents experience the parent skills training treatment will have improved outcomes over treatment as usual. the study is a pilot trial to determine feasibility for a fullscale trial.

  • The Clinical Utility of Glycated Albumin as an Index of Glycaemic Control in Type 1 Diabetic Pregnancy and its ability to predict Neonatal Outcome

    Macrosomia remains a common and important complication of type 1 diabetes in pregnancy, with adverse consequences for both mother and neonate. Accurate determination of glycaemic control remains difficult due to limitations in the accuracy of indices of glycaemic control in pregnancy and ongoing controversy regarding the timing of self-monitoring of blood glucose. Continuous glucose monitoring provides accurate glycaemic data but is limited due to cost and availability. Furthermore its use has not consistently shown improvements in pregnancy outcome. We hypothesise that glycated albumin will be a useful clinical tool for monitoring glycaemic control in pregnancy and with the availability of a new automated assay, has the potential to be widely accessable and cost effective.

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