ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Do makeup and moisturisers with SPF applied to the face provide coverage from UV radiation in adults?

    This study is aiming to assess if makeup and moisturisers with SPF applied to the face provide coverage from UV radiation in indoor workers. Who is it for? You may be eligible for this study if you are aged 18 years of age or older, work mostly indoors and use cosmetics with SPF 5 or higher on your face. Study details Participants will be asked to have a photo of their face taken using a UV camera in the morning and afternoon and provide feedback after all photos are taken in an audio-recorded interview. Participants will supply and apply their SPF product as per their usual routine. It is hoped this research will help to assess whether consumers apply their cosmetic products with SPF to ensure coverage from UV radiation throughout the day (for e.g. traveling to and from work)

  • Investigating brain health using non-invasive imaging

    The primary purpose of our study is to compare Near-infrared spectroscopy and Transcranial Doppler in terms of measuring cerebrovascular elasticity. Our hypothesis is that NiRS results will have a significant correlation with TCD-derived elasticity measurements

  • Effects of exercise on Sexual function and CArdiovascular health in men with prostate cancer (ESCA) Study

    The purpose of this research study is to implement and evaluate a sexual function and cardiovascular health-targeted intervention during and following treatment for prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and you have been, or have previously been, diagnosed with prostate cancer. Study details Participants in this study will be randomly allocated (by chance) to either 12-weeks of an exercise intervention or usual care. Participants in the exercise intervention group complete cardiorespiratory/aerobic, resistance and stretching exercises on 3 days of the week; which are individually tailored to each intervention participant. Participants in both groups are required to undertake assessments both before and after the 12-week intervention period. These assessments are related to sexual function, cardiovascular disease risk development and other health measures (e.g. body composition, blood markers, cardiorespiratory fitness). Some participants will also be invited to attend a focus group discussion on the quality and feasibility of the intervention after intervention completion.

  • Measuring the impact of dietary change on human gut microbial communities

    Aims: This project is to verify a proposed new reporting tool for determining changes in human gut communities (gut microbiome) after dietary interventions. Theory: The inclusion of fibre in the diet is associated with gut health. This is because fibre reaches the large intestine and feeds the resident microorganisms. These microorganisms in turn produce substances that benefit human health such as short-chain fatty acids. However the production of these substances varies with the types of organisms present and this in turn is dependent on the types of foods consumed. We can see these changes when different diets are consumed and these changes occur within a day of changing a diet. This gives us a valuable tool to determine which foods produce beneficial changes. However current methods of reporting changes to the microbiome are overly complex and do not provide a picture of changing gut communities that is readably visualised or rendered in a format understandable to lay persons wishing to understand how the foods they consume affect their gut communities. Methodology: The current project seeks volunteers to consume low and high fibre diets and collect a swab from their first daily faecal sample. The swab will be analysed to determine the relative abundance of each type of bacteria by modern sequencing techniques. The abundance of each type of bacteria will be compared to their base line sample, collected before they start the diet, Each type of bacteria has known associations with low-fibre or high fibre and the total number of types showing positive shifts in abundance will be tallied and graphed against those showing negative shifts. It is hoped that this new simplified way of reporting changes associated with diets will help people better visualise the important benefits of changing their diet through the effects seen on changing the gut community.

  • Two food group elimination diet versus swallowed fluticasone for the management of adult eosinophilic esophagitis, a single- centred randomised prospective study

    Eosinophilic oesophagitis (EoE) is an allergic condition which leads to inflammation of the oesophagus and subsequently difficulty in swallowing and episodes of food material getting stuck in the food pipe requiring urgent medical care. Swallowed steroid medication that coats the oesophagus and special diets that focus on eliminating dietary triggers for this allergic condition are the two modalities of treatment. This study aims to compare the efficacy of these two treatments in our local cohort of patients diagnosed with EoE. All patients with a suspicion of this condition identified at initial endoscopy will be flagged as potential participants for this study. Gastroenterologist will be informed via email regarding the trial. They will notify potential participants that a trial involving this condition is being conducted at the hospital and ask if the patients are interested. The trial doctor will then contact them and provide an overview of the study and then email information sheets to the patient. At this phone call it will also be confirmed that these patients are on medications that supress acid secretion from stomach, as per standard care. On the day of repeat endoscopy (Endoscopy 2, to repeat biopsies ), prior to sedation, patients will be approached and if they would like to participate in the trial written consent will be obtained. Subsequently they will complete questionnaires and receive blood test prior to undergoing endoscopy. These will assess the severity of symptoms and the effects of this condition on these patients' quality of life. Other patient demographics will also be collected on the day. (please see Case Report Form). The results from the second procedure ( endoscopy ) will be reviewed. If the inflammation has resolved with the acid suppressing mediation ( PPIs) patients do not have eosinophilic oesophagitis and are excluded from continuing in the trial. Patients that have ongoing inflammation despite using acid suppressing medication will be diagnosed with eosinophilic oesophagitis and will be randomly assigned to swallowed topical steroids arm or the food elimination arm. Patients randomized to the elimination diet arm will be referred to a dietician who will counsel them regarding avoiding cow milks protein and wheat. After 8 weeks of being on this diet, patients will undergo endoscopy (Endoscopy 3). On the day of endoscopy, bloods will be collected and a questionnaire will be completed. Patients assigned to the swallowed topical arm will be seen in the gastroenterology clinics, counselled regarding the use of the medication and provided with a script. After 8 weeks of swallowed topical steroids, patient will undergo endoscopy (Endoscopy 3) . On the day of endoscopy bloods will be collected and a questionnaire will be completed.

  • Investigation of the efficacy and safety of Zao Ren An Shen (ZRAS) capsule for chronic insomnia

    This study is a randomized-controlled-trial that aims to assess the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for chronic insomnia. After a 1-week placebo run-in, the participants will be randomized to either the experimental group or the placebo group and asked to take three capsule of either ZRAS or placebo every day before bedtime for four weeks. The outcomes will be assessed continuously with a sleep diary and actigraphy, and at baseline, mid-treatement (week 2), post-treatment and follow-up (week 8) with questionnnaires about insomnia severity, fatigue severity, psychological status, and quality of life. The hypothesis is that ZRAS is efficient and safe for chronic insomnia.

  • Video self-modelling using a virtual reality headset for managing freezing of gait in people with Parkinson’s disease: a feasibility study

    Freezing of gait commonly affects people with Parkinson’s disease and is known to impair mobility, increase falls risks, and reduce quality of life. The pathophysiology behind freezing of gait remains poorly understood but there is growing evidence to suggest a complex relationship between motor and non-motor factors such as cognition, mood, and environment. Pharmacological treatment is commonly offered as an intervention for freezing of gait. However, freezing of gait may persist despite optimal pharmacological intervention, especially with increased disease duration and severity. Non-pharmacological and non-surgical interventions for freezing of gait such as action observation show promise as an effective intervention to reduce freezing of gait. To date, the approach that has been tested involves: (i) the person with FOG watching video clips of an actor (without Parkinson’s disease) performing generic movement strategies to reduce freezing of gait in a clinical setting, followed by (ii) physically practising the movement strategies. The intervention that is proposed in this study is a 180 degree video self-modelling intervention using an immersive virtual reality headset, whereby the person with Parkinson’s disease observes videos of his/her own best movement strategies for preventing or overcoming freezing of gait, performed in his/her own home environment. The personalised movement strategies will be based on assessment of the individual’s motor, cognitive, emotional and environmental FOG triggers and exploration of appropriate and acceptable movement strategies for the person by a trained physiotherapist. Participants will watch their videos repeatedly (while seated), with physical practice performed separately in the context of everyday tasks. This pilot study aims to determine the feasibility and acceptability of a video self-modelling intervention using an immersive virtual reality headset for managing freezing of gait in people with Parkinson’s disease. In addition, it will evaluate the impact of the intervention on freezing of gait and on movement strategies used during freezing of gait testing. The project will provide the proof-of-concept evidence required to secure large grant funding for a randomised controlled trial to evaluate the effectiveness of the intervention.

  • Light to improve sleep, cognition, mood and day time alertness

    The daily light and dark cycle is the strongest external time cue for humans to maintain circadian rhythmicity via a specialised endogenous network. Impairment of the circadian rhythm has been shown to occur more commonly with advancing age and diminished health and as such has led to a higher prevalence of sleep disorders in the older population. Nonpharmacological strategies to treat sleep and circadian disruptions have been explored. One of these strategies being explored in this research proposal is the use of light therapy (LT). Evidence shows that LT can improve sleep consolidation, decrease daytime sleepiness and napping, realign desynchronised circadian rhythms and improve cognition. In fact, it has been shown that short wavelength light increases alertness while longer wavelength light promotes sleep. However, no research has tested LT of varying wavelengths during the day over an extended period and whether timed exposure can lead to a greater level of improvement in sleep and cognition. The study aims to demonstrate that timed exposure to a LT condition of variable wavelength for 4 days (short wavelength enriched in the day and short wavelength-attenuated in the evening) can improve sleep, mood and cognition as well as reverse melatonin suppression when compared to a control lighting condition (white light). Participants older than 50 years with self-reported poor sleep will reside, on two separate occasions, for 4 consecutive days at the Woolcock Institute in one of our research laboratory suites. Polysomnography, high density and routine electroencephalography tests will be conducted to assess sleep and brain activity and determine the primary endpoint of Wake time After Sleep Onset (WASO). Extensive neurocognitive testing using standardised questionnaires and computerised tests will occur during the study to assess cognition and used as secondary endpoints. Overall, the study will allow us to ascertain whether manipulating the spectrum and timing of light exposure can optimise nocturnal sleep, daytime alertness and improve overall quality of life.

  • Investigation of the Effects of the ‘Actipatch’ Pulsed Shortwave Therapy Device in a Chronic Low Back Pain Population at an Australian Pain Management Centre

    The ActiPatch is a small battery powered device that produces a very small electromagnetic field that you cannot feel but which early studies have found to be effective in some pain conditions. Our study aims to test what effects using this device has on pain in chronic low back pain and other aspects of the chronic pain experience. This will assist with knowing recommendations we should make to our patients about this device and how and when we might use it. As the device is relatively new on the market you would normally need to purchase this device so you will have the opportunity to trial this device at no cost to you.

  • Sex differences in exercise induced gastrointestinal damage amongst recreational athletes: A Pilot Study

    Females experience fluctuating steroid hormone profiles throughout their menstrual cycle. During the early follicular (EF) phase, characterised by the onset of bleeding, concentrations of both oestrogen and progesterone are low. Oestrogen increases, and then peaks in the late follicular (LF) phase just prior to ovulation before dropping and then increasing again during the mid-luteal (ML) phase (although not to the same concentrations as seen in the LF phase). Progesterone increases after ovulation, peaking during the ML phase and then decreasing prior to the next EF phase. There is some evidence that females tolerate gut ischemia (i.e. a lack of oxygen in the gut, often due to blood loss in circumstances such as trauma) better than males. It has been suggested that this is attributable to the protective effects of oestrogen. Interestingly, endurance exercise also causes reduced blood flow (and therefore oxygen) to the gut because blood is redistributed to the working muscles. After an hour of running at 70% of VO2 max blood flow has been shown to be reduced by 80% causing small intestinal injury similar to that induced by trauma. However, to date no study has looked at the menstrual cycle in humans in relation to changes in gut integrity in response to exercise. The aim of this study is to provide preliminary data on the potential sex dimorphism in susceptibility to intestinal damage during endurance exercise, and if this damage is menstrual cycle dependent. If differences are found, this may have implications for female athletes training and racing during different phases of their menstrual cycle.

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