ANZCTR search results

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

You can narrow down the results using the filters

32809 results sorted by trial registration date.
  • Circadian mechanisms for selective serotonin reuptake inhibitor treatment responses

    Depression is a mental illness which is the leading cause of disease burden in middle-income and high-income countries. It is characterised by low mood (i.e., feeling sad or down), loss of interest in or pleasure from things that were previously enjoyable, changes in appetite or weight, fatigue and sleep disturbance, difficulties with different thinking skills, and suicidal thoughts or behaviours. Most people with depression (up to 90%) experience sleep problems, which often precede the onset of mood symptoms. Problems with the circadian system, or ‘body clock,’ can contribute to sleep problems, and may play a role in the development of depression. We have previously found that a single dose of citalopram (an antidepressant) increases the effect of light on the body clock in health persons. This may contribute to variability in treatment outcomes in patient with depression. For example, increased light sensitivity may be beneficial for patients who were previously insensitive to light, or for those who exhibit healthy light exposure patterns (as the positive effects would be enhanced). However, for patients with unhealthy light patterns, or who are already hypersensitive, increased sensitivity due to antidepressant treatment may lead to the exacerbation of symptoms. Here, we aim to investigate the effect of chronic citalopram use on the response of the circadian system to light. Our main outcomes are the suppression of melatonin (a sleep-related hormone) and pupillary markers of light responses.

  • Assessing the Efficacy and Safety of Three iStent Inject W Implants With or Without Cataract Surgery For Patients With Glaucoma

    This is a multi-center, prospective, open-label, post-market registry of the safety and efficacy following implantation of iStent inject W stents (G2W), with or without phacoemulsification, in eyes with OAG in a real-world clinical setting. All patients will be evaluated at a preoperative visit the post-operative visita on Day 1, Week 1, and Month 1, 3, 6, 12, 18 and 24 after treatment. Slit lamp and fundus/optic nerve assessments, Gonioscopy, Pachymetry, Visual Field (VF) and Optical Coherence Tomography (OCT) assessment f Retinal nerve fiber layer (RNFL) will be performed at pretreatment baseline and at appropriate times after treatment. it is expected the intervention will demonstrate clinically significant IOP-lowering with a good safety profile.

  • Psilocybin-assisted physiotherapy for refractory Functional Neurological Disorder

    Functional Neurological Disorder is a common neuropsychiatric condition which is often chronic and results in debilitating symptoms such as weakness or sensory impairment. The symptoms of Functional Neurological Disorder are not caused by structural abnormalities within the brain or nervous system, and unfortunately no effective therapy currently exists. It is thought that drugs belonging to a class known as psychedelics, when administered in conjunction with a physiotherapy regime, may be particularly effective in the treatment of Functional Neurological Disorder but this therapeutic intervention has not previously been investigated in a clinical trial. Therefore, this study will assess the safety and obtain preliminary evidence for efficacy of psilocybin-assisted physiotherapy for patients with refractory motor Functional Neurological Disorder.

  • Implementing an evidenced based guideline for oxygen use in hospitalised adults.

    The focus of this study is on translating a guideline (to prescribe oxygen therapy for all patients who require oxygen therapy) into clinical practice based on best evidence for acute oxygen use in adults. Our objective is to improve the accurate and appropriate prescription and administration of oxygen therapy to all patients, particularly those with Chronic Obstructive Pulmonary Disease and those at risk of hypercapnoea (obese, neuromuscular disease). We hypothesise that Implementation of a multi-component intervention will be associated with improved rates of accurate prescription and administration of oxygen therapy when compared to a single component intervention.

  • To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZ-3102 (single and multiple ascending doses) in Healthy Volunteers

    This study is a prospective, randomized, double-blind, placebo controlled, two-part, Phase 1 clinical study to evaluate the safety, tolerability, PK and PD of oral single-ascending doses (SAD) and oral multiple-ascending doses (MAD) of AZ-3102 in healthy female and male subjects (between 18 and 55 years of age, inclusive), with body mass index between 18 and 30 kg/m^2. The study consists of 2 parts: SAD and MAD. A total of 88 healthy subjects are planned for the study: Part 1 (SAD): 52 subjects (6 cohorts); Part 2 (MAD): 36 subjects (3 cohorts). In the MAD part all subjects will receive once daily dosing of AZ-3102 over 14 days.

  • Effect of a multi-component intervention in post-natal mother’s groups on meeting the Physical Activity Guidelines for infants. A randomized controlled trial.

    A randomized controlled trial to determine the efficacy of a multi-component intervention incorporating WhatsApp® and group tummy time classes in post-natal mothers’ groups, on infant physical activity levels (tummy time). This will be accomplished by delivering an evidence-based intervention to mothers and their infants attending local post-natal mother’s groups. This work aligns with the “The First 2000 days” framework which is one of the priorities for the NSW Health Translational Research Grants Scheme. The participants are the parents/infants who attend ISLHD mothers’ groups and at their local Child and Family Centre. Mothers in the intervention group will be informally educated about the benefits of tummy time, positions, setting aside time and equipment. The control group will recieve usual care. We estimate that the infants in the intervention group will participate in more tummy time than those babies in the usual care group.

  • The effect of engaging fathers and daughters on girls' participation in cricket: A preliminary evaluation of the 'Daughters and Dads Cricket' program

    The Daughters and Dads cricket Program is a sport-specific variant of the highly successful ‘Daughters And Dads Active and Empowered program’. Specifically, the program aims to engage fathers in positive lifestyle role modelling and effective parenting strategies to improve their daughters’ skill proficiency in cricket, cricket enjoyment and participation, and social-emotional wellbeing. The purpose of this pre-post trial is to expand the evidence-base for Daughters and Dads Cricket from intervention testing to intervention replication (i.e., the first phase of translation research) using a quasi-experimental research design. The present study will investigate whether: a) recruitment targets are achieved and program fidelity, compliance, satisfaction, and attendance is maintained, b) the impact of Daughters & Dads cricket on daughters’: o sport-specific skill proficiency (e.g., cricket skills) o enjoyment in the sport (e.g., cricket) o intention to continue playing the sport o long-term engagement in the sport

  • The relationship between diet, dental caries risk and the glycemic index

    The consumption of sugary carbohydrate foods has been associated with changes in dental plaque pH and an increased risk of dental caries formation. The dental health impact of starchy carbohydrates, in particular, those with a high glycemic index (GI) has not been well examined. This study investigates the effect of different carbohydrate foods, varying in their GI, on acute changes in dental plaque pH. In a series of experiments in healthy adults, common starchy carbohydrate foods, along with an oral glucose solution will be consumed in fixed 25 g available carbohydrate portions. The change in dental plaque pH will be assessed postprandially over 1 hour and capillary plasma glucose concentration will be measured at regular intervals over 2 hours.

  • Effects of Exclusive Enteral Nutrition (EEN) in healthy participants

    Exclusive Enteral Nutrition (EEN) reduces inflammation and allows complete gut healing in up to 80% of people with Crohn’s Disease (CD). EEN involves removing all food and replacing it with a liquid containing all essential nutrients for 6-8 weeks. This treatment is superior to steroids in treating inflammation and is being increasingly used across Australasia as first-line therapy, particularly in children. Despite EEN having been shown to be effective in numerous studies, the ways in which it works to reduce inflammation is still unknown. To date, hypotheses as to why it may have this effect include by altering the gut microbiota, by removing potentially harmful components in the diet, by delivering nutrition directly to the gut and by allowing the gut to rest. This study seeks to address these hypotheses by assessing how EEN works. The best way to assess how a therapy works to treat disease is to examine its impact in a model of ‘normal’ and ‘diseased’ gut. This study intends to use a CD model of safely inducing intestinal stress in healthy subjects and measuring markers of subtle intestinal injury before and after they receive EEN for three weeks. By gaining a better understanding of how EEN works, we may be able to better utilise this therapy, contribute to the understanding of the relationship between diet and CD which may then assist in the development of more specific dietary therapy.

  • Prevention of SARS-CoV-2 (COVID-19) transmission in residential aged care using ultraviolet light (PETRA): a parallel crossover randomised controlled trial

    Residential aged care facilities (RACF) have experienced catastrophic outbreaks of the COVID-19 respiratory virus, yet the development of RACF-specific protective measures have been largely neglected. Commercially available upper-room germicidal ultra-violet (GUV) devices (with effective air-mixing) have been shown to be highly effective against airborne viruses, including influenza and SARS-CoV-1. Similarly, when GUV has been deployed in “in-duct” or standalone systems (wall-mounted or portable), it has been shown to result in significant reductions in both viral viability and rates of symptomatic respiratory infections. These GUV modalities might therefore be combined to achieve effective air disinfection in accordance with RACF layout, occupancy, and air ventilation setups. Our study expects to find that facility-tailored GUV strategies, as an adjunct to existing infection control measures, can substantially reduce rates of symptomatic respiratory viral infection in residents of residential aged care facilities.

Tags:
  • Finding clinical trials