ANZCTR search results

TOPAS is a parallel 1:1 randomised controlled trial (n=256) that will determine whether adding topical diclofenac gel to self-care advice with a heat pack reduces back and neck pain intensity more than providing self-care advice with a heat pack alone across the first 3 days after initiating treatment in patients with an acute episode of back or neck pain or an acute flare of chronic low back or neck pain. Secondarily, we aim to compare other clinical (e.g. disability, quality of life, use of other pain medicines) and safety outcomes between trial arms.

The aim of this study is to assess the safety and tolerability of BRD-333, an experimental new medicine being developed for the treatment of inflammatory and autoimmune conditions. The study will involve healthy volunteers who will receive either a single or multiple doses of BRD-333 or a placebo. Researchers will monitor participants for any side effects and measure how long BRD-333 stays in the bloodstream.

This study is a fully powered three-arm randomised controlled trial evaluating a consumer co-designed online body image and wellbeing intervention for adults living in Australia with inflammatory bowel disease (IBD). Participants will be randomly allocated to either the digital intervention, the same intervention plus a moderated peer-support group, or a waitlist control condition. The intervention consists of 10 self-guided online modules delivered over approximately three weeks and targets body image and wellbeing using strategies such as psychoeducation, cognitive restructuring, body functionality, self-worth, mindfulness, and self-compassion. Outcomes will include body image, body appreciation, eating disorder psychopathology, depressive symptoms, anxiety, and health-related quality of life, assessed at baseline, post-intervention, and one-month follow-up. The study aims to recruit approximately 420 participants, with around 140 participants allocated to each trial arm.

This study is aiming to evaluate whether exercise during chemotherapy infusion can improve outcomes for people with metastatic colorectal cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with metastatic colorectal cancer and have at least 5 remaining months of prescribed chemotherapy for metastatic colorectal cancer. Study details Participants will be randomly allocated (by chance) to one of two groups to receive either: 1) no exercise during chemotherapy (usual care) or 2) exercise during chemotherapy. The exercise group will complete moderate-intensity aerobic exercise for 20 minutes during each chemotherapy infusion over 6 months, supervised by an exercise physiologist. Participants will continuously wear a provided Fitbit Air to monitor their physical activity, as well as undergo routine imaging and testing and complete questionnaires during their routine appointments at the beginning, middle and end of their prescribed chemotherapy, to determine tumour response, progression-free survival, quality of life and the experience of symptoms and side-effects. At the completion of the 6-months intervention, participants will be invited to optionally attend an interview to share their experience of being involved in the study. It is hoped that this research may transform supportive care for people undergoing chemotherapy for cancer, by providing a new opportunity for exercise that addresses many of the barriers commonly experienced, along with the potential to improve clinical outcomes.

Thirst is the primary mechanism to maintain hydration status in people; a loss of body mass (sweating) should trigger fluid consumption. There is evidence to indicate that age may alter the effect of thirst on fluid consumption. Additionally, there is data to suggest that changing the fluid type with a non-nutritive sweetener may have an impact on thirst; it is unclear how age may impact this. As such, it is hypothesised that fluid consumption of both water and the non-nutritive sweetened beverage will be different between age groups. The study uses a randomised crossover design; participants will serve as their own control as they complete both experimental sessions.

This is an open-label, randomised, two-period crossover trial, testing the impact of Psychedelic Experiential Therapist Training (PETT) on psychedelic therapists’ clinical competencies. Participants will serve in two roles, with each role comprising a 5-week intervention module. After a specified period, participants will switch to the alternate role. Structured individual, co-therapy team and group support is provided throughout the intervention. Experiencer: Receive the psilocybin exposure, which involves one 30mg psilocybin dosing session and 4 non-drug psychological support sessions. Apprentice: Engage in the supervised co-facilitation module for another participant.

This study will be conducted in 2 parts. Part A will examine the safety, and Pharmacokinetics of GE8820 following a single IV or SC administration in sequential dose cohorts of healthy volunteers. Part A is planned to include 5 IV cohorts and 1 SC cohort. Cohorts may be expanded if required by the Safety Review Committee (SRC) to assess safety. Up to 3 additional cohorts may be added, if indicated to meet study objectives. Part B will examine safety and Pharmacokinetics in healthy volunteers. Part B is a multiple dose study with repeated IV and/or SC administration of GE8820 compared to placebo. One cohort is planned with up to 5 additional optional cohorts if required to meet study objectives; the IV and SC doses administered in the additional cohorts will not exceed the planned doses assessed and determined to be below the maximum tolerated dose in Part A.

This study will evaluate whether a 12-week Mediterranean-style dietary program can reduce symptoms of anxiety and depression in Australian adults. Participants will be randomly allocated to either a Mediterranean diet intervention involving dietitian support, educational resources, food hampers, supermarket vouchers and a dietary tracking app, or a befriending social support program providing equivalent contact time without dietary advice. The study will also examine whether the intervention improves diet quality, social connectedness and quality of life, and explore potential biological changes including gut microbiome composition and fruit and vegetable intake. We hypothesise that participants receiving the Mediterranean diet intervention will experience greater improvements in anxiety symptoms, depressive symptoms, and dietary adherence than those receiving the befriending control condition

This is a single-centre, two stage, open label study to investigate the tolerability and feasibility of a new intranasal delivery system. 10 healthy controls and 20 schizophrenia consumers will be recruited to self administer an intranasal spray for 14 days and provide feedback on tolerability of the delivery system. We aim to address a gap in the therapeutic options available for individuals using long term antipsychotic treatment.

This study aims to find out whether bronchoscopic radiofrequency ablation can be safely added to standard chemotherapy and immunotherapy that is given before patients with non-small cell lung cancer undergo surgery (IMPRINT study). Who is it for? You may be eligible to join this study if you are aged 18 years and older with confirmed Stage IIA-IIIA Non-Small-Cell Lung Cancer (NSCLC) and recommended for neoadjuvant Chemo-immunotherapy followed by a lobectomy for resection. Eligible participants will have a pre-ablated parenchymal tumour/lesion size of greater than or equal to 20mm and will have a planned ablation zone margin of greater than or equal to 10mm away from the pleural surface, mediastinum, diaphragm and/or spine. Study details Bronchoscopic radiofrequency ablation (RFA) where a RFA catheter is introduced to the lung cancer via a bronchoscope, will be delivered to patients with confirmed resectable non-small cell lung cancer prior to recieving standard of care neo-adjuvant chemo-immunotherapy followed by resection. One ablative procedure per patient will be performed by a trained interventional pulmonologist. Procedure will be performed in an operating theatre under general anaesthesia. Patients will be followed up from time of ablation to resection. This study will identify whether bronchoscopic thermal ablation prior to neoadjuvant chemo-immunotherapy can be performed without compromising the delivery of standard neoadjuvant care and will assess the proportion of eligible patients (Resectable Stage II–IIIA, candidates for chemo-IO) who consent to the add-on ablation procedure, the rates of patients completing treatment and progressing to surgery, patient pathologic responses, and any side-effects or adverse events. It is hoped that the findings of this study will help to determine if bronchoscopic tumour ablation for immune priming can be used to enhance neoadjuvant chemotherapy and immunotherapy in patients with resectable NSCLC.