ANZCTR search results

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

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31214 results sorted by trial registration date.
  • 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.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • Intestinal barrier function in response to physiological stress

    Intestinal barrier perturbation is a central mechanism to a multitude of diseases but its function has proven elusive to measure. Clearer experimental models of barrier dysfunction induction and reliable non-invasive markers are required. Currently we do not have a good way to intestinal permeability or 'leaky gut' The aim of this study is to help develop blood tests which will help with this measurement. We hypothesise that both the high fat, high carbohydrate meal as well as the injection of corticotropin releasing hormone will cause a significant disruption to the intestinal barrier function that will be measurable with the blood tests that we are testing.

  • Multilayer Silicone Dressings as Compared with Standard Care for Prevention of Sacral Pressure Injuries in Community Cancer Patients: A Cluster Randomised Control Trial

    Pressure injuries, also commonly known as pressure ulcers or bedsores, are wounds considered adverse events when acquired in care. Pressure injuries are a burden to patients and their carers, due to pain and distress and can decrease the quality of life. This study aims to determine the usefulness and cost-efficiency of two different silicone dressings compared to usual care for the prevention of pressure injuries in cancer patients who are in palliative care. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have a primary diagnosis of any cancer, and you score three or over on the Resource Utilisation Groups – Activities of Daily Living (RUG-ADL) questionnaire. Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. All three groups will receive standard care for the prevention of pressure injuries, which includes risk assessment, skin inspection and the implementation of appropriate support surfaces (bed and chair seating devices) and repositioning equipment (hoist or slide sheet). It also involves the provision of patient and caregiver/family prevention education, including equipment use and maintenance, the need for regular repositioning, skincare and advice to optimise nutrition for the hospice patient. Participants allocated to group 1 will also have multilayer silicone dressing Brand 1 applied to the sacrum (lower back near buttocks). The dressing will be changed three times a week during the usual nurse visit schedule for at-risk palliative care patients or sooner if the dressing becomes dislodged. Participants allocated to group 2 will also have multilayer silicone dressing Brand 2 applied to the sacrum (lower back near buttocks). The dressing will be changed three times a week during the usual nurse visit schedule for at-risk palliative care patients or sooner if the dressing becomes dislodged. Participants allocated to group 3 will not receive any additional dressings and will be managed via standard care practices only. All participants will receive this care for up to 4 weeks following enrolment, unless they deteriorate, develop a pressure injury or need to be transferred to a hospital or other care facility. It is hoped this research will determine whether the use of silicone dressings is practical and has any impact on the prevention of pressure injuries compared to usual care practices. If the silicone dressings are more effective than usual care, they may be implemented across other care facilities to improve the quality of life for future cancer patients.

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