ANZCTR search results

Brief description of the study purpose This study is investigating whether faecal microbiota transplantation (FMT) can improve the effectiveness of the immunotherapy drug cemiplimab in people with advanced cutaneous squamous cell carcinoma (cSCC). Researchers will also examine whether changes in the gut microbiome following FMT are associated with improved immune responses and better cancer outcomes. Who is it for? You may be eligible for this study if you are a male or female aged 18 years and older with locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) who have not previously received immunotherapy targeting PD-1, PD-L1 or CTLA-4 pathways and are suitable to undergo colonoscopic FMT. Study details All eligible participants will receive standard treatment with cemiplimab every three weeks, together with two faecal microbiota transplantation (FMT) procedures delivered by colonoscopy over a six-week period. All participants will also follow a study-prescribed whole-food, plant-enriched diet designed to support gut health throughout the study. All participants will receive the study treatment. Participants will be assigned to receive either a single-donor or two-donor FMT formulation. As part of the study, participants will undergo colonoscopies, blood tests, stool sample collection, questionnaires, and other assessments to monitor changes in the gut microbiome, immune system activity, treatment response, and safety. Participants will be followed for up to two years, with long-term safety monitoring continuing for up to ten years after study completion. It is hoped that this research will determine whether FMT can enhance responses to immunotherapy in advanced cSCC and contribute to the development of new treatment approaches for patients who currently have limited therapeutic options.

Psychological distress affects over one in five university students, harming their study, work, relationships, and wellbeing. Brief, smartphone-based programs targeting mindfulness, sleep, and physical activity can reduce distress, but not all students benefit equally. This study will explore whether “amotivation” – including low drive, loss of interest, and reduced social engagement – helps explain why some students respond less well to these interventions. Using our MindGRID digital phenotyping app, we will collect passive smartphone data (e.g., movement, location, phone use) alongside brief self-reports to identify digital patterns linked to amotivation. We will then test whether these digital profiles can predict and help personalise the delivery of smartphone interventions to improve mental health in university students.

This project seeks to enhance women’s access to primary care provision of LARC and EMA by addressing healthcare practitioner barriers and integrating these aspects of reproductive health into locally-available, community-based services. Lack of familiarity with LARC among health professionals and misperceptions about their use (e.g. many GPs falsely believe that IUDs are contraindicated in nulliparous women) have a profound effect on the advice given to women and limit women’s options. Lack of education and training for GPs and other health professionals and lack of follow-up support after training (e.g. supervision, mentoring) are also real issues. Further to this, integration of EMA into general practice has recognised barriers – some GPs feel EMA is beyond their scope of practice or that they would be stigmatised. Many feel isolated and speak of the need for peer support and referral pathways to assist them. It is anticipated with this intervention that primary care clinicians will benefit from the increased support and education, enhanced teamwork and networking with colleagues in the community, and connection to services and service providers to help women achieve their reproductive goals.

Although sodium glucose transporter inhibitors (SGLT2i) are approved in Australia (TGA) for the treatment of children with type 2 diabetes (T2D), their use in people with type 1 diabetes (T1D) is not approved due to the increased incidence of DKA. However, trials have utilised risk-minimising strategies in children and adults to reduce DKA and gain the overall benefits of SGLT2i in diabetes management. This study utilises a Dual Glucose and Ketone (DGK) monitor with a management plan to recognise early ketosis and intervene appropriately. This is a 14-week randomised controlled study in children with T1D on SGLTi (dapaglifozin). Two ketone thresholds available in real-time from DGK monitor will be evaluated at 1.0 mmol/L and 1.5 mmol/L with education provided regarding the user intervention. The primary objective is to determine whether DGK in conjunction with user response initiated at 1.0 mmol/L is more effective than 1.5 mmol/L in reducing the time spent with ketone levels greater than or equal to 3.0mmol/L. In this randomised parallel-arm study, participants will undergo a 2-week run-in period and will then be randomly assigned 1:1 to two groups. Group 1 will receive education about Algorithm 1 (responses at ketone threshold of 1.0 mmol/L) and Group 2 will receive education about Algorithm 2 (responses at ketone threshold of 1.5 mmol/L).

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, sequential single-ascending-dose (SAD) followed by multiple-dose (MD) trial in healthy adult participants aged between 18 and 65 years old. Participants will be enrolled into 1 of 3 cohorts – each cohort testing a different dose of the study drug WIN027. Participants will be dosed as in-patients at the study site and then will be followed up with multiple follow-up visits over a period of 36 weeks. The study drug WIN027 is being developed for the treatment of moderate-to-severe uncontrolled asthma and chronic obstructive pulmonary disease.

This study is testing a new gel product called Tutelix™ TL150, which is injected between the prostate and the rectum in men with prostate cancer to act as a physical cushion ("spacer") during radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have histologically confirmed adenocarcinoma of the prostate who is a candidate for external beam radiotherapy and have not had the prostate removed. Study details Participants will be randomly allocated (by chance) to one of two groups to receive either 1) Tutelix spacer and fiducial markers a week before radiotherapy or 2) fiducial marker insertion a week before radiotherapy. Fiducial markers are considered standard of care. Participants will undergo assessments to record medical history and current medications, PSA blood test results and radiotherapy planning MRI and CT scans and questionnaires. During the follow up period all participants will complete questionnaires, have visits with the study doctor to assess any adverse events and the patients who received the Tutelix spacer will also have MRI scans. These visits will occur at the end of radiotherapy treatment, 3 months, 6 months, 12 months and 18 months to determine the radiation dose received during radiotherapy, incidence of adverse events and quality of life. This study will assess the effectiveness and safety of the Tutelix spacer to improve outcomes for patients requiring radiotherapy for prostate cancer.

Approximately 12 healthy participants will take part in this study to compare how the body absorbs GV-100 when taken with food and without food. Each participant will receive the study drug under both conditions, with a 7-day break between doses. Participants will undergo screening, stay at the study center during dosing visits for monitoring, and attend a follow-up visit after completing the study. The study will only begin after earlier safety results have been reviewed and found acceptable.

In this trial, 48 healthy volunteers will undergo application of the CRAB device at a pressure of 20cmH2O for 2 minutes and 40cmH2O for a further 2 minutes. Volunteers will have their vital signs monitored with non-invasive blood pressure (BP), electrocardiogram (ECG) and pulse oximetry (SaO2). Volunteers will also complete a post intervention questionnaire regarding, discomfort, pain, difficulty breathing and the ability to provide additional anonymous feedback.

Agomelatine is a clinically validated medicine approved in some countries for the treatment of anxiety and depression, but its use has been limited because much of the drug is broken down by the liver before it reaches the bloodstream. GlyphAgo is an investigational oral prodrug of agomelatine designed to overcome this limitation and improve how the drug is absorbed in the body. This study will evaluate two doses of GlyphAgo to determine whether the potential sleep benefit in patients with anxiety symptoms and sleep disturbance, and whether it is safe and well tolerated.

After heart surgery, 30-90% of patients receiving medications to boost their blood pressure, which can lead to illness, death, and healthcare costs. In this study, we randomise patients to receive calcium infusions vs. a placebo (a lookalike medication with no effect) to assess if calcium can help reduce the burden of blood pressure boosting medications. We hypothesise that delivering calcium infusions in this trial is safe, and will show a preliminary signal in reducing vasopressor requirements.