ANZCTR search results

This study, conducted at the University of Canberra Hospital, is focused on evaluating the level of acceptance and use of a novel AI-enabled robotic system designed for Rapid Response Systems. Through the use of a detailed questionnaire, the research aims to gather insights into the social, ethical, and safety concerns associated with this technology. The findings will not only gauge user acceptance but also guide us in refining the design of the robotic system, ensuring it is developed in a more human-centered way, taking into account the needs and perspectives of healthcare professionals, patients, and visitors alike.

This project is designed to assess the safety, feasibility and preliminary efficacy of psilocybin-assisted therapy (PAP) for body image disturbance (BID) in individuals with a history of anorexia nervosa. Participants will receive three doses of psilocybin alongside 14 sessions of therapy. Female participants will be required to have a history of anorexia nervosa. These participants will be medically stable and in a range of weight restoration, with a minimum body mass index (BMI) of 18.5 and will have persistent BID. Participants will also be required to have had a minimum of one episode of evidence-based care for their eating disorder. Participants will be expected to nominate an adult caregiver (“Support”, e.g. parent, partner, sibling, etc.) to participate in the study. Participant Supports will be required to commit to 3 non-dosing sessions.

Patients often experience low blood pressure following major surgery, which may be an emergency situation that could compromise organ function and lead to complications and even death. The trial is a pilot trial of tablet-based therapies that increase the blood pressure and see if they would be useful to prevent low blood pressure after surgery in preparation for a large definitive study in the future. The pilot trial will examine how many patients can be enrolled, as well as how acceptable the trial is to patients, clinicians and researchers, whether there are any problems in the design or execution of the trial and whether the consent procedures which have had to be specially designed for the complex situation after surgery are acceptable. The two medications being tested are widely used in clinical practice to treat low blood pressure that occurs when part of the nervous system does not regulate blood pressure properly called orthostatic hypotension, which the researchers believe there is a mechanism linking this problem to low blood pressure after surgery. Any treatment that could prevent this complication of surgery while being simpler than current options like admission to intensive care would be an important development. This pilot trial will establish the groundwork for a definitive clinical trial in the future that would aim to help reduce the risk of complications and promote recovery after surgery while using health resources efficiently.

This study is designed as an open-label study to evaluate the PK profile, comparative bioequivalence, safety, and tolerability of Smartech Formulation 2 (2 percent w/w diclofenac sodium topical solution) and diclofenac 2%, applied to both knees of healthy adult male and female participants twice a day for 7.5 days. The study will be conducted in up to 90 evaluable participants. Evaluable participants are defined as those who have completed a treatment period with diclofenac 2% and a treatment period with Formulation 2, with a washout period between the 2 treatments of at least 14 days. These participants may be by either: Participants who were treated with Pennsaid and were included in the study PK population in the SMTPK001 study, and to whom only Smartech Formulation 2 will be administered in this study, or Participants who were not treated in the SMTPK001 study, and to whom Smartech Formulation 2 and diclofenac 2% will be administered in this study following a crossover design, with a washout period between treatments of at least 14 days.

Dietary therapies are at the forefront of irritable bowel syndrome (IBS) management, but their restrictive nature has led to concern they may cause disordered eating. This study seeks to understand if dietary treatment influences disordered eating in IBS, and to clarify the validity of screening tools in this population. We will recruit 27 patients with IBS from the community. Participants will be provided with the first-line dietary treatment for IBS, the low FODMAP (fermentable carbohydrate) diet by a specialist dietitian. Participants will meet with the dietitian twice (Week 0 and Week 6) for 1 hour each, and have additional support via the Monash University Low FODMAP App. At weeks 0 and 6, participants will complete questionnaires (assessing symptoms, dietary intake, and disordered eating screen) and meet with a provisional psychologist to assess for disordered eating. The primary aim is to assess the number of participants classified as meeting disordered eating criteria based on a psychologist’s clinical assessment following the intervention. Secondary aim is to compare the reliability of a screening questionnaire compared to the psychologist’s clinical assessment.

One in five young Australian adults have a sleep problem which warrants clinical review. Most of the time, these sleep problems are not well managed. One in four young Australians also work shift work. The combination of shift work and an unmanaged sleep problem can put young adults at risk of road safety incidents. The overall purpose of this study is to determine whether a sleep education module followed by experience of a shift work simulation, can support faster access to appropriate health services for sleep.

Sleep is an important activity for ensuing health and recovery from illness. Sleep deprivation is known to be associated with several comorbidities including obesity, diabetes, anxiety and depression, hypertension, heart disease and stroke and increased risk of death. Sleep deprivation is also known to be associated with impaired cognition, impaired immune function and could make people less morally aware. Sleep in intensive care unit (ICU) was shown to be of a poor quality by several studies including from our group. However many of these studies assessed sleep using subjective tools such as Richard Campbell Sleep Questionnaire, self-reported sleep quality by patients and nurse, or clinician observations. These subjective tools, while they are simpler to use, are not reliable and can over- or underestimate the sleep quality and duration. Some objective tools such as Actigrapy and Bispectral Index were used for sleep evaluation but are not gold standard to evaluate sleep. In this study we propose to use Polysomnography which is considered to be gold standard for studying sleep. We aim to study the sleep of patients who are on a mechanical ventilator and receiving some of the commonly used drugs to promote sleep.

The purpose of this study is to assess the efficacy of an intervention for grief and loss in adolescents aged 13-17 living in Australia. The selected intervention is a cognitive behavioural approach aiming to assist adolescents to deal with grief and loss. It is an online, unguided intervention consisting of eight modules across four weeks. Adolescents self-pace themselves through two modules per week engaging in cognitive and behavioural activities. We predict that treatment will improve symptoms of anxiety, depression, post-traumatic stress disorder and prolonged grief, and improve well-bring.

The Take Control - Live Well program is a self-management program for adults living with at least one chronic condition. We have based the program on the Flinders Program which was designed for use in one-on-on consultations. This study is to explore the effectiveness of applying the Flinders Program to a group program setting in providing self-management support for adults living with chronic conditions. We hypothesise that the Flinders Program will be feasible and effective in a group setting.

Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 7 women and those assigned female at birth in Australia. Endometriosis has a significant impact on one's physical, psychological, and social wellbeing. Unfortunately many of the pharmaceutical medications for endometriosis have bothersome side effects or should only be used for a short period of time due to concerns related to dependence and addiction. Medicinal cannabis has well described analgesic, anti-inflammatory, anxiolytic, anti-depressant, and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, for cannabis. Our previous research has shown that women with endometriosis in Australia are using mostly illicit sources of cannabis to manage their pain and other symptoms. We hypothesise that either a balanced THC:CBD oil or CBD alone will reduce pelvic pain and other symptoms in women with endometriosis. The primary aim of this study is to determine the efficacy and safety of two medicinal cannabis products compared to placebo in women with endometriosis.