ANZCTR search results

Complex perianal Crohn's fistulas are common with poor healing rates and high relapse rates despite long-term immune medications and repeated surgical procedures. Local fistula injection of stem cells derived from fat tissue is a new effective treatment.. We have completed a Phase I study using local injection of amniotic epithelial cells from the placenta in 10 adults with refractory complex Crohn's and reported the treatment as safe, well-tolerated and there was fistula improvement in 8 of 10 patients. In this study, we are using stem cell products produced from the amniotic cells instead as they also have medicinal properties. Participants will receive one or two injections of stem cell products into the fistula during examination under anaesthesia and undergo assessment using routine colonoscopy, blood tests, stool tests and MRI scans. We hypothesise that these stem cell products will be safe, well-tolerated and feasible to inject.

This study seeks to examine the efficacy of integrated psychological therapy for co-occurring traumatic stress and substance use among adolescents and young adults aged 12-25 years, delivered in person and via telehealth (i.e., video conferencing). Through this trial we hope to improve our understanding of how best to treat young people experiencing traumatic stress, who are also using alcohol or other drugs, and provide evidence for interventions with maximum reach and accessibility. Eligible participants will be randomly allocated to receive one of two treatments: i) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered via telehealth; or ii) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered in person. Both treatments consist of up to 16, one-on-one, sessions with a psychologist. Participants will also be asked to complete three research interviews at baseline (i.e., study entry), 4- and 12-months post baseline. The primary outcome is change in PTSD symptom severity. It is expected that pre- to post-treatment reductions in PTSD symptom severity in participants receiving COPE-A via telehealth will be non-inferior to reductions observed among participants receiving COPE-A in person. A range of secondary outcomes will also be examined including changes in substance use, emotional functioning and health-related quality of life.

The main aim of the study is to evaluate the safety and tolerability of single doses of APG990 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as atopic dermatitis, which is the anticipated main therapeutic use for APG990.

Based on the findings of a previous research findings (RMIT Ethics Ref: 24895), we noted that a digitally delivered Qigong program for older adults, the Qigong Plus Program, was both feasible and acceptable amongst pilot study participants. Therefore, this follow-up project will build upon previous findings and deliver an enhanced Qigong program for older adults that employs additional behaviour change interventions strategies to sustain participant engagement, both during the program and subsequently promoting long-term Qigong practice. The use of pre-recorded sessions allows the participant freedom to decide the timing for their program delivery, resulting in a heightened sense of perceived self-agency towards their health.

This project intends to implement the co-designed endometriosis guidelines into an Australian workplace, and seeks to understand if and how the education, supports and accommodations offered within the guidelines enable people with endometriosis to manage their pain while working; understand the impact of the guidelines on work and wellbeing outcomes for those with endometriosis; explore ways in which the guidelines impact workplace culture and support; and to refine and provide recommendations to finalise a set of national employer guidelines to support employees to manage endometriosis and to assist their supervisors to do so. It is hypothesised that after 12 months of the endometriosis guidelines being implemented, that employees with a diagnosis with endometriosis will have improved health-related quality of life, improved work outcomes (presenteeism, absenteeism, and retention). Additionally it is hypothesised there will be an improved perceived level of managerial support and improved workplace culture as perceived by the staff at the targeted workplace.

Rhinitis affects approximately 20 to 40% of the population and is currently poorly controlled in approximately 15% of the population with standard treatment. Botulinum toxin type A spray could provide a painless, easily applied and potentially alternate treatment for sufferers. Currently there is wide use in cosmetic clinics but few supporting clinical trials. . HYPOTHESIS We aim to test the hypothesis that botulinum toxin type A is an effective treatment for rhinitis when delivered via intranasal spray, as measured by total nasal symptom score. INTERVENTION 40 units Botulinum toxin type A administered topically intranasally using the LMA® MAD Nasal™ Intranasal Mucosal Atomization Device by Teleflex (ARTG number 294634). 20 units will be administered per nostril at the base line visit of the study.

The theory of planned behaviour is based on the premise that individuals will formulate plans of action based on the information and knowledge available to them. The study uses this theory to investigate whether the delivery of a one-month educational information package to young adults via email and text message will increase dietary fibre consumption. Dietary surveys delivered before and after the intervention will measure any alterations in dietary behaviour. Surveys relating to mood will evaluate any impacts of fibre intake on anxiety and depression. We hypothesise that increasing awareness of the benefits of dietary fibre consumption via education will lead to improved dietary behaviours.

This study aims to address the lack of information on the efficacy and safety of surgery in combination with chemotherapy (FLOT) alone OR chemotherapy, radiotherapy and immunotherapy (CROSS/nivolumab) in treating cancers involving the lower oesophagus and the junction of the oesophagus and stomach (GOJ cancers). This lack of information may lead to significant variations in practice as clinicians lack the evidence to help decide which treatment is best for their patients. This has led to unnecessary harm and even deaths due to potentially avoidable treatment complications and early cancer recurrence. Who is it for? You may be eligible for this study if you are aged 18 years and over, with adenocarcinoma involving the lower oesophagus and GOJ who underwent surgical resection. Received either neoadjuvant CROSS chemoradiation + adjuvant nivolumab OR perioperative FLOT chemotherapy between 1st January 2017 to 31st December 2023. Study details For all participants, information regarding survival and disease progression (identified clinically, biochemically, and/or radiologically) will be obtained from your electronic medical record, with no study visits or additional testing required. This data will be used to compare the survival and disease progression between different treatments. It is hoped that this research will determine how immune cells within these cancers respond to the different treatments, which will serve to inform clinicians of the optimal, personalised treatment for their patient that derives maximal benefit whilst reducing harm.

Endometriosis is a complex and chronic condition impacting one in ten women. There is an average of 4-9 years between the onset of symptoms and receiving a diagnosis due to difficulties distinguishing between normal and abnormal period pain, and the long wait times and costs associated with diagnostic testing. Prior research has shown that women with endometriosis are increasingly turning to social media for information, and often perceive personal anecdotes as more valuable than scientific content in making medical decisions. In the current study, we will experimentally test with female participants aged 18-45 years the influence of social media content and source credibility on their hypothetical intention to seek diagnostic testing for endometriosis. This study will illuminate the features of social media posts that may shape women’s intentions to pursue endometriosis diagnosis and treatment, and further our understanding of the impact of social media on medical decisions.

Semaglutide is a long-acting GLP-1 analogue used in the treatment of patients with type 2 diabetes (T2D) has shown to improve glycaemic control and result in meaningful weight loss. The drug has a well described safety profile including a low risk of hypoglycaemia. This short duration pilot study will evaluate the biological activity of a single dose of 4mg of oral Semaglutide in Diabetology’s Axcess formulation. Eight healthy volunteers will receive 4mg of the encapsulated semaglutide on an empty stomach with a glass of 100ml of water, on Day 0. They would also have received a placebo 2 days prior to this. Both the placebo and the semaglutide will be administered on the same day, in a fasting state. An intravenous glucose tolerance test (IVGTT) will be conducted two hours after placebo and treatment, before any food is consumed. The IVGTT will also be performed at approximately the same time on days 1, 4 and 6 post-treatment. The primary aim of the study is to determine whether, compared to a placebo, orally delivered encapsulated semaglutide is associated with a difference in plasma blood glucose levels during an intravenous glucose tolerance test (IVGTT). The secondary aims are to 1) explore changes in plasma insulin during an IVGTT, and 2) to explore the duration of action over a span of 7 days.