ANZCTR search results

We seek to evaluate the effectiveness of a pilot adaptation of Mother-Infant Dialectical Behaviour Therapy (MI-DBT), an evidence-based therapy for mothers with Borderline Personality Disorder. We will collect measures related to sense of parenting confidence, severity of borderline personality and depression amongst other measures, and interview participants about their experience of participating in the group.

The aim of this research project is to evaluate proof of concept - change in mechanistic and clinical outcomes, and feasibility and acceptability of a newly developed online FODMAP (LFD) diet intervention. The FODMAP diet is an evidence-based therapy and first-line intervention for the management of IBS. The specific aims of this research are: To evaluate if the online FODMAP diet program can achieve a pre-specified minimally clinically important change (MCIC) in: i. Total FODMAP intake; and ii. Gastrointestinal IBS symptoms. To evaluate if the online FODMAP diet program can be implemented as designed specifically addressing: i. recruitment, ii. trial processes and procedures including completion of primary outcome measures, participant engagement with the program, and therapist intervention; and ii. program acceptability. We hypothesise that the online FODMAP diet program will achieve a clinically meaningful change in total FODMAP intake and gastrointestinal IBS symptom improvement; and that the online FODMAP diet program will be feasible and acceptable to participants as indicated by meeting a priori identified benchmarks. We anticipate that the post treatment qualitative interviews will facilitate further refinement and optimisation of the online treatment prior to conducting the proposed randomised controlled trial.

The trial is to test a new device and determine if scrotal cooling improves semen quality. We expect to observe an improvement in all measured semen parameters (morphology, motility, concentration, DNA damage) with the use of the scrotal cooling device.

The purpose of this study is to evaluate the extent of scar formation and to provide safety information for a new approach to scar formation after s surgical procedure. TetraDERM device uses the natural heat from the body to form an elastic hydrogel scaffold, the controls moisture within the wound bed whilst providing a cushioning effect physically to reduce the tension of the wound. TetraDERM creates an environment for new skin tissue to form that is similar to our bodies natural healing response. TetraDERM’s capability to control the hydration within the wound bed, to reduce wound tension and support healing work to reduce scar formation. Up to 8 subjects will be enrolled at one clinical site in Australia in cohort 1. There will be a total of 11 subject visits occurring over 12 months.

Preeclampsia and hypertensive disorders of pregnancy are associated with a significant increase in the risk of developing early onset cardiovascular diseases, including heart failure. This project is investigating the ability for isometric handgrip echocardiography to detect early signs of diastolic dysfunction in the heart, prior to changes being observed by traditional resting echocardiography and clinical signs of heart failure. This may facilitate future studies into early intervention in this population.

Psilocin (4-Hydroxy-N,N-dimethyltryptamine) is the active form of the prodrug psilocybin (3[2(dimethylamino) ethyl]-1H-indol-4-yl] dihydrogen phosphate). Psilocybin is a natural product produced by numerous species of Psilocybe mushrooms. In humans, psilocybin is not detectable in systemic circulation or in target organs after oral administration as the phosphate group of psilocybin (a tryptamine derivative) is rapidly enzymatically cleaved to the active pharmacologic moiety psilocin . Thus, studies administering psilocybin are by default results for psilocin due to the almost immediate conversion of psilocybin to the active form psilocin. Administration of TRP8803 IV over a controlled time has potential advantages over oral administration of psilocybin such as improved control over blood levels of psilocin, faster entry into the psychedelic state, better control over the duration of the psychedelic state, and increased safety due to rapid offset of effects and avoidance of peak blood levels (Cmax) associated with oral administration. From a clinical research perspective TRP-8803 provides a mechanism to explore both the depth and duration of the psychedelic experience and how these parameters affect clinical outcomes. Infusing TRP-8803 with a bolus over the first 20 minutes (loading dose) allows attainment of Cmax in a controlled protocol and subsequent infusions for a total of 7.5, 14, or 20.5 mg over 140 minutes allows for maintenance of the psychedelic experience at a therapeutic dose. IV administration allows for the physician to control and optimize the psilocin dose.

The purpose of this study is to assess the safety and tolerability (how well a treatment can be tolerated by a patient) of EBC-1013 Gel. This study will be conducted in patients with Venous Leg Ulcers, aged 18 years and above. This study will compare EBC-1013 Gel with placebo. A placebo is a medication with no active ingredients. It looks similar to the real thing, but it is not. Participants enrolled in this study will be placed into one of five different groups. Each group will receive a single treatment with one of five different dose levels of EBC-1013 Gel (0.1, 0.3, 0.6, 1.0 and 1.5 mg/g). One participant in the first three dose concentration groups will receive placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. Each group will involve a minimum of 3 participants. A maximum of 7 participants will be enrolled in each cohort, if any safety signals are observed in that cohort.

The purpose of this trial is to investigate the acute dose-related effects of intraduodenal administration of calcium on gastrointestinal functions, associated with the regulation of appetite and energy intake, in healthy participants.

Stroke affects approximately 1 in 4 people in their lifetime, but is highly preventable through effective management of risk factors such as smoking, inadequate diet, high blood pressure and physical inactivity. Love Your Brain is a digital platform to improve the knowledge of Australians in stroke prevention, by helping people identify and manage their risk factors for stroke. We will determine the feasibility and acceptance of the implementation of the proposed intervention in a sample of attendees of Stroke Foundation StrokeSafe presentations and obtain data to inform the design of a fully powered randomised controlled trial.

Chest pain is the leading cause of Ambulance Victoria attendance and costs $337 million per year. Currently, all patients with chest pain are transported to hospital, but half will be discharged safely from Emergency Departments, at a cost of $135 million every year. We have developed a new Ambulance Victoria clinical practice guideline (CPG) for these low risk patients using risk assessment, point-of-care blood testing by paramedics, and Victorian Virtual Emergency Department consultation with referral for follow-up in the outpatient or general practice setting. We will now conduct a comprehensive evaluation of the new CPG via a randomised trial with safety, effectiveness, quality of care, process, and economic components. The outcomes span from the rapid reduction of ED overcrowding and ambulance ramping in the short term to the development of streamlined follow-up pathways and significant cost savings in the medium and long term. Through this innovative model, we will optimise patient outcomes and contribute to a more efficient and economically sustainable healthcare system for the benefit of all stakeholders.