ANZCTR search results

The aim of the study is to collect prospective data on the treatment outcomes in patients with first localized, resectable recurrent retroperitoneal liposarcoma undergoing curative intent treatment. Who is it for? You may be eligible for this study if you are aged 18 or older presenting with first recurrent liposarcoma of retroperitoneal space or pelvis after previous macroscopically complete resection. Study details Patients enrolled in this study will form a validation cohort of the TARPSWG recurrent RPS nomogram. The treatment decision (surgery alone +/- post operative treatments, or surgery with preoperative RT +/- post operative chemotherapy) is per the institutional multidisciplinary team recommendation. There are no additional tests above standard of care tests involved in this project. There will be a quality of life questionnaire that will be administered at 4-5 different timepoints throughout the study. It is hoped that findings from this study will further medical knowledge about the treatment for this type of sarcoma and hence improve outcomes for patients with recurrent retroperitoneal liposarcomas in the future.

Every year, nearly 250,000 Australian university students report suicidal thoughts and behaviours, but are reluctant to seek support. We have developed a novel screening tool that accurately identifies students at increased suicide risk, and proactively reach out to offer safety planning and support. Our initial work shows this is associated with a 41.7% reduction in suicidal behaviour one year later (this work was not pre-registered). In this project, we will extend this program to support university students across the country. We anticipate that a similar effect will be observed in the larger study.

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 each of the 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 4 participants (1 placebo and 3 active). A maximum of 7 participants will be enrolled in each cohort (1 placebo, 6 active) 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.