ANZCTR search results

This study aims to evaluate a new needle-free method of administering fertility medication during elective egg freezing. Women undergoing egg freezing will be randomly allocated to receive Menopur either by the standard daily injections or through a small soft catheter placed under the skin that remains in place for several days, reducing the need for repeated needle injections. Both methods use the same medication and standard treatment protocol. The study will compare the number of eggs collected, treatment safety and participant experience, including pain, needle anxiety, convenience, treatment burden and overall satisfaction. Participants in the study will receive their stimulation medication and catheter devices at no cost. It is expected that the needle-free approach will produce similar ovarian response while improving the treatment experience. The findings will help determine whether this method is a safe and effective alternative to daily injections and inform future studies in IVF patients.

This study will investigate whether seated or standing eccentric calf-raise training produces greater changes in the structure of the soleus (calf) muscle. Participants will complete an eight-week calf-strengthening program using either seated or standing calf raises. We expect that seated calf raises will produce greater increases in soleus fascicle length. Changes in soleus muscle structure, calf strength, endurance and jumping performance will be measured before and after the training program. The findings may help identify which calf-raise exercise is more effective for targeting the soleus during training and rehabilitation.

PAL-001 is a randomised pilot trial testing a psilocybin-augmented professional development program with group facilitation on social attitudes in politically engaged adults. The 13-week program combines structured group facilitation, delivered to two groups of 8 participants, with one supported 30 mg psilocybin session per participant. Participants are randomised to one of two program schedules, and all complete the same program. The main hypothesis is that social attitudes will change from baseline to Week 14, and the trial also assesses safety, acceptability and preliminary effects. Secondary measures include social distance, cognitive flexibility, empathy and wellbeing, with follow-up to Week 52.

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, adaptive trial designed to evaluate the efficacy and safety of ARG-007 in participants with anterior circulation acute ischemic stroke (AIS) due to large vessel occlusion (LVO) undergoing endovascular thrombectomy (EVT), with or without concomitant intravenous (IV) thrombolytic therapy. The trial will be conducted at multiple sites across Australia and the United States, including Comprehensive Stroke Centers and high-volume thrombectomy-capable hospitals experienced in the management of AIS and the conduct of interventional clinical trials. ARG-007 is a neuroprotective agent that has been evaluated in a Phase 1 first-in-human dose escalation safety trial (ARG-007-001) and a randomized Phase 2 proof-of-concept trial (ARG-007-002) in LVO AIS participants undergoing EVT. The primary objective of the study is to evaluate the effect of ARG-007 on achieving clinically meaningful functional outcomes measured 90 days after experiencing an AIS and undergoing EVT by comparing ARG-007 to placebo. Upon meeting eligibility criteria, participants will receive blinded treatment as a single 10 minute IV dose as soon after randomisation but before successful reperfusion. Participants will be followed for up to 90 days to evaluate effects on functional outcomes, including functional independence in activities of daily living.

The study is a 2-part, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of AKV9 in approximately 72 healthy adult participants. In Part A a total of approximately 56 male and female healthy adult participants will be enrolled in a total of 7 sequential treatment cohorts to receive a single, oral dose of AKV9 or placebo under fasted conditions. In Part B a total of approximately 16 healthy adult participants aged 18 to 55 years will be enrolled in a sequential fashion to 1 of 2 treatment cohorts to evaluate the effect of multiple-dose administration of AKV9 on safety and PK parameters. Participants will receive AKV9 or placebo once daily for 10 days.

This study aims to determine the cost-effectiveness of Multimodal Pulmonary Nodule Assessment strategies using Shape-sensing Robotic-assisted Bronchoscopy in patients being investigated for a suspected lung nodule, as part of the COMPASS Study. Who is it for? This study is for adults aged 18 years and older with a high-risk peripheral pulmonary nodule (screen-detected or incidentally identified), referred for diagnostic biopsy at Royal Prince Alfred Hospital, including cases requiring concurrent EBUS-guided mediastinal nodal sampling. Participants must be able to provide informed consent. Study details This study will evaluate the accuracy, safety and cost-effectiveness of a new type of lung biopsy, obtained by robotic bronchoscopy, sometimes guided by a 3D scan (cone-beam CT), against the usual percutaneous (through the skin) needle biopsy, for diagnosing small lung nodules. In Arm 1 of this study, patients referred for bronchoscopic lung nodule biopsy will undergo robotic-assisted bronchoscopy using cone-beam CT guidance (RAB-CBCT), performed by credentialed, appropriately trained interventional pulmonologists at Royal Prince Alfred Hospital. Arm 1 also includes patients who underwent robotic bronchoscopy at Royal Prince Alfred Hospital as routine clinical care prior to ethics approval; for these patients, only medical record data will be used, with their consent. In Arm 2 of this study, patients requiring lung nodule biopsy will undergo percutaneous nodule biopsy (where suitable), instead of RAB-CBCT, performed by trained, appropriately credentialed interventional radiologists at Royal Prince Alfred Hospital. Arm 3 will consist of a retrospective cohort of patients who have already undergone percutaneous nodule biopsy, whose existing data will be integrated into comparative analyses. Cost-effectiveness (incremental cost-effectiveness ratio and cost per quality-adjusted life-year) will be assessed using a 12-month economic model, combining quality-of-life questionnaires completed by participants in the weeks after their procedure with medical record data on diagnosis, complications, and healthcare costs collected over the following 12 months. Proportion of procedures resulting in a specific tissue diagnosis (malignant or benign) will also be assessed through pathological review. It is hoped that the findings of this study will help decide whether this newer technology should be used more widely across NSW public hospitals in the future.

Coronary artery disease can occur even in people without the traditional risk factors such as high cholesterol, diabetes, smoking, or high blood pressure. Per- and polyfluoroalkyl substances (PFAS) are manufactured chemicals that may contribute to the development of coronary artery disease, but it is not currently known whether reducing PFAS levels improves heart health. The purpose of this study is to determine whether regular plasma donation over 12 months can reduce PFAS levels and slow the progression of coronary artery disease in adults with greater PFAS exposure levels and evidence of non-calcified plaque in their coronary arteries. Participants will be randomly assigned to either begin plasma donation immediately or after a 12-month delay. The hypothesis is that reducing PFAS levels through regular plasma donation will slow the progression of coronary artery plaque compared with deferred plasma donation.

In this randomised, double-blind, placebo-controlled study, 120 adults aged 18 years and older experiencing at least mild depressive symptoms and elevated psychological distress will be randomly assigned to receive one of two doses of Hedonia or a matching placebo for 8 weeks. Hedonia is a nutritional supplement containing omega-3 fatty acids, S-adenosyl-L-methionine (SAMe), and L-methylfolate. The primary aim is to determine whether Hedonia reduces overall psychological distress, including symptoms of depression, anxiety and stress, compared with placebo. Changes in depressive symptoms, mental wellbeing, mood, sleep quality and energy levels will also be assessed throughout the study. All assessments will be conducted remotely, and treatment adherence, tolerability and adverse events will also be evaluated.

This study is a clinical trial in healthy volunteers to understand how safe AP03 is and how the body processes it. AP03 is an investigational medicine being studied to help slow lung scarring and preserve lung function in people with idiopathic pulmonary fibrosis (IPF). Healthy volunteers will be randomly assigned to receive either AP03 or a placebo in single ascending dose (SAD) or multiple ascending dose (MAD) cohorts. Doctors will closely monitor participants for side effects. The study uses gradual dose increases, small participant groups, and close medical supervision to help ensure participant safety before progressing to higher dose levels.

This study aims to find the highest dose of an investigational drug called Sapu006 that can be given safely. Sapu006 is a new form of the chemotherapy drug docetaxel. It packs docetaxel into tiny particles so it doesn’t need to be dissolved in a solvent, which may cause side effects in some patients. Laboratory studies suggest Sapu006 behaves in the body much like standard docetaxel. This study will check its safety and measure how the body handles it. The study will also look at whether the amount of a protein called albumin in the blood and in the tumour is linked to how well the treatment works. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older with one of the following conditions: locally advanced or metastatic breast cancer that has grown after previous chemotherapy advanced or metastatic non-small cell lung cancer that cannot be removed by surgery and has grown during or after platinum-based chemotherapy metastatic castration-resistant prostate cancer metastatic epithelial ovarian, fallopian tube or primary peritoneal cancer, with no more than 2 previous lines of chemotherapy. You will also need a blood albumin level of at least 4.0 g/dL and a suitable sample of your tumour. A study doctor will do health checks to confirm whether you can take part. Study details All participants will receive Sapu006 as a 1-hour infusion into a vein once every 3 weeks. Before each infusion, participants will receive medicines to help prevent allergic reactions. Depending on the type of cancer you have, you may also receive a second, approved cancer medicine that is commonly given with docetaxel: Participants with breast cancer or non-small cell lung cancer will receive Sapu006 alone. Participants with prostate cancer will also take prednisone tablets. Participants with ovarian, fallopian tube or primary peritoneal cancer will also receive an infusion of carboplatin (another chemotherapy drug) straight after the Sapu006 infusion. The first participants will receive a low dose of Sapu006. A safety committee will review the results for each small group of participants before higher doses are given, and the dose can also be lowered if needed. Treatment can continue for as long as it is helping and the side effects are manageable. During the study, participants will have regular check-ups, blood tests and scans, and will be asked to report any side effects. In the first 2 treatment cycles, extra blood samples will be taken to measure Sapu006 levels, and participants may need to stay in hospital for up to 2 days after the infusion. A stored sample of each participant’s tumour will be tested for albumin gene activity. If no stored sample is available, a new biopsy may be taken if it is safe to do so. It is hoped this research will identify a safe dose of Sapu006, given alone or with prednisone or carboplatin, for future trials. It will also give an early indication of whether Sapu006 can help control these cancers.