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Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN).
This study aims to determine whether delivery of bowel preparation instructions for a colonoscopy through dynamic multimedia instructions (scheduled SMS, smartphone application, video instructions, and email) has an impact on the quality of bowel preparation, diagnosis rate and colonoscopy procedure times compared to instructions that are given verbally, in hard copy or via email only. Who is it for? You may be eligible for this study if you are aged 45 years or older, you have been scheduled to attend a colonoscopy as an outpatient to screen for potential colorectal cancer and you have access to a smartphone. Study details All participants will be instructed to take either a ‘Standard Bowel Preparation’ or 'Enhanced Bowel Preparation' depending upon their bowel habits. The only difference between the groups is how the instructions for bowel preparation will be delivered. All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive their bowel preparation instructions either by SMS, video and through a smartphone app, or to receive their instructions verbally, in paper/hard copy format or email only. Participants who are allocated to the SMS/smartphone group will receive 1-3 daily reminders throughout the week prior to their colonoscopy and will be asked to enter details about their preparation each day for 1 week prior to the colonoscopy. This should only take 2-5 minutes per day. Participants who are allocated to the paper/email group will receive a copy of the instructions once only and will not receive any reminders prior to their colonoscopy. All participants will be asked to complete a series of questionnaires after their colonoscopy, this is anticipated to take 10 minutes. It is hoped this research will demonstrate whether a more interactive delivery of instructions for colonoscopy has any impact upon the ability to diagnose bowel cancer and the ease of the procedure itself. If this method is successful, it may be implemented on a larger scale which could improve the diagnosis and treatment of bowel cancers.
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A Three Part, Randomized, Double-Blind, Placebo-Controlled, Phase I Study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GXV-001 in Healthy Volunteers
This is a randomised double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted in three parts: • Part A: A single ascending dose (SAD) part where dose levels will be evaluated in a sequential manner starting at the proposed lowest dose level in healthy volunteers. • Part B: A multiple ascending dose (MAD) part where dose levels and final numbers of subjects will be evaluated depending on SAD results in healthy volunteers. • Part C: Evaluation of a single dose in healthy male and female volunteers between 50 and 75 years of age. Part A will enrol up to 40 healthy volunteers in a total of 5 cohorts. Each cohort will enrol 8 participants with 6 participants randomised to receive GXV-001 and 2 participants randomised to receive placebo. Part B will enrol up to 48 healthy volunteers will be enrolled in a total of 3 cohorts. Each cohort will enrol a minimum of 8 and a maximum of 16 participants with up to 12 participants randomised to receive GXV-001 and 4 participants randomised to receive placebo. Part C (Elderly Cohort) will enrol approximately 8 healthy volunteers between 50 and 75 years of age (inclusive) in a single cohort, with 6 participants randomized to receive GXV-001 and 2 participants randomized to receive placebo. Up to three dose levels will be evaluated in Part B. The starting dose and number of participants enrolled in MAD cohorts for Part B will be selected following completion of Part A. The total maximum study duration for participants in Part A is 43 days (for SAD Cohorts 1, 2, 3, 4 and 5), inclusive of visit windows. For SAD Cohorts 1, 2, 3, 4 and 5, this includes a screening period of up to 28 days (Day -35 to Day -8), outpatient sleep control period (actigraphy) from Day -8 to Day -1, confinement to the clinical facility over 2 nights (Days -1 to Day 2) and one outpatient visit at the end of the study (Day 7 ±1 day). The total maximum study duration for participants in Part B is 44 days (for MAD Cohorts 6, 7 and 8), inclusive of visit windows. This includes a screening period of up to 28 days (Day -28 to Day -1), confinement to the clinical facility over 7 nights (Days 1 to Day 8) and one outpatient visit at the end of the study (Day 15 ±1 day). The total maximum study duration for participants in Part C is 36 days inclusive of visit windows. This includes a screening period of up to 28 days (Day -28 to Day -1), confinement to the clinical facility on Day 1 and one outpatient visit at the end of the study (Day 7 ±1 day).
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A feasibility study evaluating a structured telehealth Lifestyle intervention (Exercise And Diet) for early-stage Breast Cancer Survivors (LEAD-4-BCS) undergoing neo-adjuvant/ adjuvant chemotherapy
Being overweight/obese and physical inactivity have been associated with increased cancer risk and all-cause mortality. Modifying lifestyle risk factors can decrease cancer recurrences and improve outcomes. Therefore, the aim of this study is to assess whether a structured lifestyle intervention delivered using an innovative method (virtual platform) in the early stage of breast cancer treatment has the potential to lead to earlier adoption or maintenance of a healthy lifestyle. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of early-stage breast cancer, and are being treated with either neo-adjuvant (i.e. before surgery) or adjuvant (i.e. after surgery) chemotherapy with curative intent for a minimum of 12 weeks. Study details All participants will take part in a 14-week virtual lifestyle intervention during chemotherapy treatment. This will involve a weekly 1-hour exercise session supervised by an exercise physiologist, and 1-hour dietary education session facilitated by a dietitian for 10-weeks, then fortnightly sessions for 4-weeks (total 24-sessions). The exercise prescription includes home-based exercise and involves resistance (e.g. exercise resistance band). Dietary sessions involve education about healthy eating, and strategies to improve psychosocial wellbeing. At the beginning and end of the 14-week intervention, participants will complete a number of online questionnaires to assess adherence to the intervention, satisfaction, safety, quality of life, and any lifestyle modifications. Participants will also undergo a number of tests of physical health remotely at the beginning and end of the intervention. These outcomes will be re-assessed at 6 months after commencement of the intervention, to determine whether any changes are sustained over this period. Participants will need to complete a daily diary including questions of physical activities and diet during 14-week intervention. It is hoped that this study may show that a virtually-delivered lifestyle intervention improves adoption and maintenance of a healthy lifestyle, which may lead to an improvement in quality of life and longer-term health outcomes for cancer survivors.
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Effects of calcium and amino acids on gut hormone secretions and bone turnover in males with obesity (with or without impaired glucose tolerance or type 2 diabetes)
The purpose of this trial is to investigate the effects of calcium alone and in combination with the amino acid, L-tryptophan, on gastrointestinal functions, associated with the regulation of appetite and energy intake in males with obesity (with or without impaired glucose tolerance or type 2 diabetes).
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Optimizing telemedicine delivery in out-patients
The key objective of this study is to define the strengths and limitations of telemedicine and virtual care from the perspective of key stakeholders in care, specifically patients, carers, clinicians, and administrators in hospital ambulatory (outpatient) settings.
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Examining the effect of superior vs temporal laser peripheral iridotomy in adults with primary angle-closure glaucoma or angle-closure suspect
Laser peripheral iridotomy is used to treat narrow and closed-angle glaucoma and eyes with narrow anterior chamber angle to prevent progression to glaucoma. The laser peripheral iritodomy can be done in any location in the peripheral iris, however traditionally, it has been performed in the superior 12 o’clock position. The superior and temporal (3 o’clock for left eye, 9 o’clock for right eye) sites are the most common sites for laser peripheral iridotomy. Rarely, some patients may experience visual disturbances after laser peripheral iridotomy. These are known as dysphotopsia symptoms and typically described as grey or blue horizontal or slightly curved line. The purpose of this study is to assess the whether superior or temporal placement the iridotomy hole is associated with incidence of dysphotopsia symptoms. The hypothesis is that superiorly placed laser peripheral iridotomies are associated with reduced incidence of dysphotopsia symptoms.
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The Wellbeing Neuro Course: A Randomised Controlled Trial of an Online Treatment Program for Adults with Multiple Sclerosis
Mental health (e.g., anxiety, depression) and functional difficulties (e.g., cognitive problems) are highly comorbid in people with Multiple Sclerosis (MS). However, access to effective psychological treatments are limited. People with MS face many barriers (e.g., costs, limited trained clinicians, mobility issues) accessing effective psychological care. The Wellbeing Neuro Course offers an innovative solution to these barriers and aims to improve access to effective psychological care for adults with MS within the Australian healthcare system. The Course uses the principles of both cognitive behaviour therapy and compensatory cognitive rehabilitation to target several domains of mental health and functional disability. The purpose of this project is to assess the acceptability, feasibility and effectiveness of an established internet-delivered psychological treatment, the Wellbeing Neuro Course, in reducing symptoms of depression, anxiety and disability in patients with Multiple Sclerosis, The study also aims to gather critical data of the characteristics of patient’s response to treatment. it is hypothesised that: (1) the program will be highly acceptable and that high levels of engagement will be observed; (2) the program will require relatively little clinician time to administer; and (3) preliminary evidence of improvements in disability, anxiety, and depression will be observed at post-treatment and maintained at 3-month and 12-month follow-up in patients with MS.
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The effects of the bitter agonist, quinine, on gastric emptying in healthy normal-weight volunteers.
The aim of the study is to assess the effect of a bitter compound, quinine, on gastric emptying and intragastric distribution of a mixed solid-liquid meal, using the ‘gold standard’, scintigraphy, secretion of glucoregulatory hormones and postprandial blood glucose. We have recently established that quinine, when allowed to sufficiently interact with small intestinal bitter receptors, reduces postprandial blood glucose by stimulating glucoregulatory functions, including slowing of gastric emptying and stimulating glucoregulatory hormones. Gastric emptying was measured by 13C-acetate breath test, a non-radioactive, non-invasive test that provides a broad indication of the relative effect on gastric emptying, but does not allow quantification of gastric content over time, or examination of intragastric meal distribution. However, scintigraphy is the ‘gold standard’ for the measurement of both liquid and solid gastric emptying. Moreover, this technique allows quantification of intragastric meal distribution, i.e. both proximal and distal gastric contents.
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Using advanced neuroimaging techniques to measure sexual dysfunction following spinal cord injury
Sexual dysfunction is a significant personal and social problem for people living with a spinal cord injury (SCI). The capacity for penile erection and vaginal lubrication is preserved to some extent, either through psychogenic or reflexogenic sexual response to stimulation. However, the ability to achieve orgasm is impaired and in turn, this can negatively impact personal relationships, quality of life, sexual satisfaction, and male fertility. An understanding of the altered neural circuitry contributing to sexual dysfunction in the context of SCI is therefore necessary in order to meet an unmet need for viable therapeutics. This project will assemble evidence about spinal cord and brain involvement in the initiation and maintenance of reflexogenic and psychogenic sexual responses using functional magnetic resonance imaging (fMRI). It is important to try to understand the relative contribution of signalling in spinal cord and brain circuits and pathways to sexual arousal in males and females and to relate this to the pathophysiology of sexual dysfunction in SCI.
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A micro randomised trial (MRT) to test the effects of app-based motivational messages on physical activity and heart rate.
The aim of this study is to evaluate the effectiveness of context-specific physical activity recommendations and activity plans for increasing physical activity in adults with a previous diagnosis of coronary heart disease. (A) The investigators hypothesise that: Primary hypothesis: 1. Participants will show a greater improvement in steps walked within 180 minutes of receiving motivational messages compared to not receiving the motivational messages. Secondary hypotheses: 2. Participants will show a greater improvement in physical activity duration and heart rate within 180 minutes of receiving motivational messages compared to not receiving the motivational messages. 3. Certain times of the day will be more effective in the proximal outcomes in those randomized to the intervention compared to those who are randomized to not receive the intervention. 4. There will be no difference in distal outcomes in Phase 1 of the study compared to Phase 2. (B) Physical activity can be tracked via Fitbit devices, which our participants will wear 24/7 during the intervention period which will be 90 continuous days at time points 4-6 and 10-12 months. (C) Baseline data will be collected for a full one month prior to initiating the intervention for the initial 4-6 months, and at month 9 (natural baseline) for the 10-12m study period. (D) Our intervention will be sent as messages (seen as notifications via the app) according to a random schedule to participants who will be randomised (to either receive or not receive the messages) at each time-point per day during the intervention period. (E) We will have a smartphone app adapted for this research and we will implement this MRT through it. (F) Data from this MRT will allow us to further design just-in-time interventions for future digital interventions. Just-in-time interventions are simply providing the right support (messages) at the right time. (G) The purpose is to provide behavioural support directly corresponding to real-time needs when participants can participate in positive behaviours. (H) Our hypothesis suggests those participants receiving the intervention messages will show an improvement in physical activity compliance, improvement in heart rate variability, and improvement in heart rate, with an overall improvement in cardiometabolic health at the 12-month time point. (I) 58 participants will be randomised for 90 days at two time points (4-6m and 10-12m).