ANZCTR search results

This research project is being conducted to look at the pharmacokinetics of both DUR-928 and Midazolam; this is done by measuring the amount of DUR-928 and Midazolam in the blood at different times throughout the dosing periods. Data from this study will allow us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream) and it will allow us to determine the impact of DUR-928 on how Midazolam is handled by the body.

A randomised controlled trial will be used to investigate the effectiveness of the iChooseWell program. The iChooseWell program will be offered through the My Digital Health platform. People visiting the website, in response to advertisements or through self-interest, will be informed of the availability of the iChooseWell program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program condition or a delayed access condition (8 week delay). The iChooseWell eHealth program consists of 41 biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from the array of biopsychosocial strategies available within iChooseWell. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful resources are provided (e.g., self-monitoring, ‘On the Go’ mobile tools). Each individual wellness strategy is between 2-6 pages (taking between 5-20 minutes to read) and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10 minutes per day on average) to complete offline to practise the principles of the chosen wellness strategies. Participants will also receive automated emails (e.g., remind them to log on, when to complete post/follow-up questionnaires). The iChooseWell program includes text, graphics, audio, video, interactive games, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices. Participants randomised to the iChooseWell immediate access group will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessment, post-intervention assessment (Week 5) and a 1 and 3-month follow-up assessment (Week 9 and Week 17). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to the iChooseWell digital health program following the 1 month follow-up assessment (Week 9). However, the delayed access group will be asked to complete the post intervention assessment after they have completed the iChooseWell program (Week 13) and a 1 month follow-up (post program) (Week 17). Access to iChooseWell will be provided for the entire trial period. Engagement will be measured by the number of strategies visited by post assessment (measured via passive analytics). It is expected that people who undertake iChooseWell immediately will show greater reductions in negative affect and increases in mental health and wellbeing and optimism and at post-intervention and the 1 month follow-up time point, as compared to the delayed access group.

An automated (self-help) decision-support crisis and suicide prevention program (called iConsiderLife) will be evaluated. The iConsiderLife program is one of the My Digital Health platform programs. People visiting one of the My Digital health sites will be able to find a link to iConsiderLife within the ‘Crisis and General Support Services’ page. This page provides the general public with information and links to crisis and mental health service providers. In response to clicking the iConsiderLife link or hearing about the iConsiderLife site, people will be invited to participate in the study. People wishing to participate in the iConsiderLife evaluation study will be provided with immediate access to the program, following the provision of their informed consent to participate in the study and answering several brief demographic / personal questions. People who do not wish to participate in the evaluation study or are under 18 years of age will be provided with a list of alternative sources of support. iConsiderLife is designed to provide people who are currently distressed or experiencing a crisis with a simple, step-by-step, problem solving approach design, to assist in reducing this distress in real time. There are six key sections that participants are guided through one by one. If a person was to say ‘no’ to each question within the program, it would take them approximately 3 minutes to complete. People are asked their age, gender, what country they reside in, postcode if Australian, whether or not they are currently under the influence of alcohol and other drugs, and their current level of distress (from 0 – 100). Once people reach the end of iConsiderLife, or opt out early because they are no longer feeling as distressed, the person is asked to re-rate their distress level and they are then provided with some additional feedback / information. The flow (e.g., what sections people visit most) and their before and after distress ratings will be explored to examine the effectiveness of the program. It is expected that people who use the iConsiderLife program will feel less distressed once they have finished using it.

A cognitive behavioural and biopsychosocially-based program for decreasing symptoms of post-traumatic stress, as well as anxiety and depression (called LIFE FLeX 4 PTSD), will be evaluated. LIFE FLeX 4 PTSD is one of the digital health programs offered through the My Digital Health platform. People visiting the platform, in response to advertisements or through self-interest, will be informed of the availability of the LIFE FLeX 4 PTSD digital health program and invited to participate in the study. People taking part in the study will be provided with immediate access to the program, following completion of the pre-intervention schedule. LIFE FLeX 4 PTSD is designed to provide people with information and strategies to address their post-traumatic stress, anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module, delivered over 8 weeks. There will also be a short ‘Booster’ Module released in Week 11. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, to complete their daily mood survey, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each module to help evaluate the module they previously completed. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-8) assessments, post-intervention assessment (Week 9) and a 1 and 3 month follow-up assessment (Week 13 & Week 21 respectively). Participants will also be asked questions relating to their program engagement levels at post assessment. Program access will continue for another 8 weeks post the 3 month follow-up assessment (Week 29). It is expected that people who undertake LIFE FLeX 4 PTSD program will show reductions in post-traumatic stress, anxiety and / or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation.

A cognitive behavioural and biopsychosocially-based digital health program (called iSleepWell) for decreasing insomnia and stress symptoms will be evaluated.iSleepWell is one of the digital health programs offered through the My Digital Health platform. People visiting the iSleepWell site or the My Digital Health platform, in response to advertisements or through self interest, will be informed of the availability of the iSleepWell program and invited to participate in the study. Consenting participants will be provided with immediate access to the iSleepWell digital health program, following completion of the pre-intervention schedule. iSleepWell is a self-help digital health program designed to provide people with information and strategies to address their insomnia and stress symptoms. iSleepWell contains five core modules, delivered over 7 weeks. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities per week. Participants will also receive automated emails (e.g., to remind them to log on, to complete their daily mood survey, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each module to help evaluate the program modules. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 2, 4, 6) assessments, post-intervention assessment (Week 8) and a 1 and 3 month follow-up assessment (Week 12 & Week 20 respectively). Participants will also be asked questions relating to their program engagement levels at post assessment. It is expected that people who undertake iSleepWell will show reductions in their insomnia symptoms at post-intervention and follow-up assessment time points, as well as decreases in stress, anxiety and or depressive symptoms.

An open trial will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health can be accessed on multiple devices (desk top, tablet and mobile). People, who visit the website, either directly or through seeing the study advertised, will be invited to take part in the BDZ digital health evaluation study. BDZ digital health is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. Each module will take approximately 20 minutes to complete. Participants will receive automated emails (e.g., when to complete the during, post/follow-up intervention questionnaires). During the course of the study we strongly encourage participants to work with their doctor should they decide to reduce their benzodiazepine dosage as well as seek specialist benzodiazepine telephone support from Reconnexion. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessments, a post-intervention assessment (Week 6) and a 3 and 6 month follow-up scheduled assessment (Week 18 & Week 30 respectively). Participants will continue to have access to the program until Week 38 (8 weeks following the 6 month assessment). Participants will be asked questions to ascertain reasons for engagement or lack of engagement with the program. It is expected that people who undertake BDZ digital health will show reductions in their benzodiazepine dependency, anxiety and / or depressive symptoms at post and 3 and 6 month follow-up time points.

A randomised controlled trial will be used to investigate the effectiveness of the iMindTime program. The iMindTime program will be offered through the My Digital Health platform. People visiting the website, in response to advertisements or through self-interest, will be informed of the availability of the iMindTime program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7-week delay). The iMindTime digital health program consists of six brief sessions, over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accepting what is there without wanting it to change in any way. Participants will spend three days on each session before moving onto the next session. Each session will require 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. Participants will also receive automated emails (e.g., remind them to log on, when to complete questionnaires) and will be asked to self-monitor their mood and lifestyle events. Participants randomised to the iMindTime digital health (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime digital health program following the 1 month follow-up assessment (Week 8). However, the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindeHealth program (Week 11). It is expected that people who undertake iMindTime immediately will show greater reductions in negative affect and increases in mental wellbeing at post and 1 month follow-up time points, relative to the delayed access group.

A transdiagnostic, cognitive behavioural and biopsychosocially-based digital health program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated. LIFE FLeX digital health is one of the digital health programs offered through the My Digital Health platform. People who consent will be given access to the LIFE FLeX program immediately but are randomly allocated to one of two groups: 1) LIFE FLeX digital health program A (immediate access to all of the program modules) and; 2) LIFE FLeX program B (weekly, sequential release of the program modules). LIFE FLeX is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short ‘Booster’ Module released in Week 10. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked to self-monitor their mood and daily lifestyle events (e.g., sleep) and asked several questions at the beginning of each module, to monitor their progress. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-7) assessments, post-intervention assessment (Week 8) and a 1 and 3-month follow-up assessment (Week 12 & Week 20 respectively). It is expected that people who undertake LIFE FLeX will show reductions in anxiety and / or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation.

Preservatives in eye drops, such as benzalkonium chloride (BAK), are necessary to prevent microbial contamination, but have been known to affect the comfort and health of the eye's structures, especially if used for long periods of time. This study will investigate the impact of BAK in participants using preserved and unpreserved atropine eye drops on their ocular comfort and health, as well as on the action of the drug itself.

Bone remodelling involves a process of continuous bone resorption and formation through the co-ordinated recruitment of osteoclasts (bone resorbing cells) and osteoblasts (bone forming cells), and it is well recognised that the bone marrow provides the progenitor cells (mesenchymal and hematopoietic stem cells) needed for such processes to occur. Mesenchymal stem cells (MSCs) give rise to bone (including osteoblasts), adipose tissue and muscle, while the hematopoietic stem cells (HSCs) give rise to the blood cells (including osteoclasts). Many studies have attempted to investigate factors that regulate the bone remodeling process, with vitamin D as a popular choice due to its known beneficial effects in bone conditions such as osteoporosis in the elderly. Although its effect on osteoblasts, osteoclasts and myocytes are well known, the effects on the progenitor cells are not. Currently, the origin of osteoblastic cells is not as well understood as osteoclastic cells. With ageing, there is a significant reduction in the number and quality of the osteogenic precursors within the bone marrow, which is more prominent in osteoporotic bone. This has allowed researchers to hypothesise that increasing the number of osteoblast precursors in bone could be used as a new approach to osteoporosis. However, one of those potential therapeutic options involves an invasive and complex technique of bone biopsy with aspiration to obtain such progenitor cells for ex-vivo culturing and re-implantation for treatment in osteoporotic patients. This has led to the research of less invasive techniques that aim to assess the quality and quantity of such progenitor cells without the need of invasive procedures, with one such development being the discovery of circulating osteogenic progenitor (COP) cells within peripheral blood. COP cells are considered as a surrogate of MSC population in the bone marrow and are implicated in processes such as the pubertal growth spurt and frailty. Presently, there are few interventional studies regarding COP cells described in the literature. As such, more should be done in an attempt to explore and further characterise the biology of COP cells and their exact role in bone formation. In addition, COP cells could become a biomarker for diseases that affect MSC population, such as sarcopenia and osteoporosis, and also as an indicator of the therapeutic response to treatments that induce bone formation. There have been many studies recognising various compounds that affect bone. Vitamin D is one of those compounds with an anabolic effect on bone and also as an inhibitor of bone marrow adipogenesis. In this study, we hypothesise that individuals who are deficient in vitamin D will have a relatively lower number of COP cells as compared to healthy individuals. Secondly, we also hypothesise that the beneficial effect of vitamin D supplementation on human bone is associated with increasing numbers of COP cells.