ANZCTR search results

This is First in human, open label, single centre, exploratory study to determine safety and PK characteristics of INS018_055 after a single IV microdose administration in healthy participants. This study will enrol 8 eligible adults. The study will consist of 3 periods: Screening-(Day -28 to Day-1)- After completion of ICF and eligibility check participants will be enrolled in the study. Treatment period (Day-1 to Day -2)- On Day 1, baseline and safety assessments will be performed and participants will be administered a single dose of IP via IV injection and monitored for safety. Blood for PK analysis will be collected pre and post dosing. Follow up (Day 8[± 1day]- Participants will return to CRU on Day 8 to undergo safety assessments.

Antiva is developing ABI-2280, a potent human DNA polymerase inhibitor, for topical treatment of several precancerous conditions related to human papillomavirus (HPV) infection, including high grade squamous intraepithelial lesions (HSIL) of the cervix. The purpose of this study is to assess the safety, tolerability and PK of ABI-2280 Vaginal Gel and Tablet, applied to the cervix of healthy female participants. The study will be conducted in two parts: Part A (Single Ascending Dose) and Part B (Multiple Ascending Dose). Part A There will be 4 Cohorts in this part, A1 -A4, each consisting of 8 participants. 6 participants will receive a single dose of ABI-2280 and 2 will receive a single dose of placebo. No participant will be enrolled in more than one cohort. Participants will be screened up to 49 days prior to dose administration. Participants may be admitted to research unit on Day -1 or morning of Day 1 and remain admitted until Day 2. On Day 1 participants will receive a single dose of ABI-2280 Vaginal Gel or Tablet or placebo. They will return to the clinic on Day 4 for safety follow up visit and Day 8 for end of study visit. Part B Up to approximately 16 participants will be enrolled into two cohorts- B1 and B2. Each cohort will consist of 8 participants (6 to receive ABI-2280 Vaginal Gel or Tablet and 2 to receive placebo). Participants will be screened up to 49 days prior to Day 1 dose administration. For cohorts B1 and B2, participants may be admitted to the research unit on Days -1 and 4 and discharged on Days 2 & 6 or if feasible, may be admitted through Day -1 to Day 5 and discharged on Day 6. On Days 1 & 5, they will receive the first and last doses of ABI-2280 Vaginal Gel or Tablet or placebo. Participants will have safety assessments and ABI-2280 or placebo administration on Days 3, safety follow-up visit on Day 9, and the End of Study (EOS) visit on Day 15.

The study will be a randomised, placebo-controlled single-blind parallel-group trial; over a 36 week period. The primary objective in this study is to determine percentage change in body weight with 36 week treatment with subcutaneous semaglutide versus placebo, adjusted for baseline weight period for patients with schizophrenia or schizoaffective disorder. Specifically, it is hypothesised those participants allocated to the active arm semaglutide treatment will have a greater reduction of percentage body weight at week 36 compared to individuals taking placebo.

This 4-week pilot study aimed to determine the feasibility and acceptability of performing a pragmatic resistance ‘exercise snacking’ program performed once, twice, or thrice daily in community-dwelling older adults when delivered and monitored remotely. Secondary aims were to: 1) explore the dose-response effects of ‘exercise snacking’ on physical function, 2) determine the feasibility of conducting physical function assessments remotely within the homes of participants using videoconferencing, and 3) explore the participants experience and perceptions of the ‘exercise snacking’ approach. It was hypothesised that the exercise program would be feasible (mean of 80% of prescribed sessions completed) for all daily exercise frequencies and it would also be feasible to perform the physical function assessments remotely using videoconferencing.

This trial aims to determine whether NOX66 (idronoxil) can be safely given in combination with nivolumab (an immune checkpoint inhibitor) and to determine the highest dose of NOX66 that can be administered safely. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a confirmed diagnosis of solid advanced, metastatic tumour that is potentially amenable to treatment with nivolumab. You may already be receiving a checkpoint inhibitor (nivolumab or other) and have minor disease progression, or you may have minor disease progression on chemo- or targeted therapy and have never received a checkpoint inhibitor. Study details Participants who choose to enrol in this study will undergo 14-day treatment cycles with nivolumab, which will be administered via a needle into their vein on the first treatment day. Participants will also receive NOX66 as a suppository on days 1-7 of each treatment cycle. Combination treatment may continue for up to 2 years. Continuation of the combined treatments will depend upon whether the treatments have an effect on tumour growth and whether participants experience any significant side effects while on treatment. During the treatment cycles all participants will be monitored for side effects and will also undergo imaging (CT or MRI) at 2, 4, 6, 12 and 18 months after the start of Cycle 1, and at the End of Study (Month 24) or Early Termination. Bone scans will also be performed in patients where the cancer has spread to the bones. Bone scan will be done at screening if no recent scan (within 6 weeks), and at 6, 12, 18 and 24 months after the start of Cycle 1. It is hoped this research will demonstrate that NOX66 in combination with nivolumab is safe and that the optimal dose of NOX66 for the treatment of solid tumours can be determined. If NOX66 and nivolumab are shown to be safe and effective, these treatments may be used to improve outcomes for future cancer patients.

This study aims to determine if high volume HCLA SSNB injection leads to decreased pain and improved functional outcomes, when compared with low volume injection in patients with rotator cuff tears. This will be a landmark study for SSNB HCLA injection volumes in the literature. This research will help create a standardised process for the administration of HCLA SSNB injections. At present, there is no protocol or guidelines in place that guide SSNB volumes. Evidence based processes could be created with this research and will have the effect of reliable and reproducible treatment which increase the efficacy and safety of treatment for patients.

The trial will recruit participants who have, in the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. Participants must have, since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction (PCR) of pharyngeal swab or on a rapid antigen test (RAT) and be asymptomatic of: fever, new cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual. Participants will be randomized 1:1 to receive either Ivermectin 200ug/kg orally or Placebo on Day 1. The trial will recruit until 40 participants have converted to a positive PCR or TGA-approved RAT for SARS-CoV-2 within 14 days of their contact with an infectious SARS-CoV-2 index case. Amongst the 40 participants who convert to a positive PCR or positive TGA-approved RAT for SARS-CoV-2, the proportion who received Ivermectin. Specifically, the trial will test whether that proportion is less than half.

Biliary or pancreatic stents are used for management of ductal obstruction. Currently, biliary or pancreatic stents are made of either plastic or metal alloy. As a result, repeat endoscopic retrograde cholangio-pancreatography (ERCP) is necessary for stent removal. Our aim is to study the feasibility, safety and technical performance of the novel bio-degradable stent (ARCHIMEDES) in 3 patient groups: (1) Post liver transplant duct to duct anastomotic strictures; (2) hepaticojejunostomy anastomotic strictures and (3) patients requiring post ERCP pancreatitis prophylaxis with pancreatic stent placement.

This study is aimed at testing the effectiveness and cost-effectiveness of the RecoverEsupport digital health program in supporting colorectal cancer patients undergoing surgery. Who is it for? You may be eligible for this trial if you are aged 18 years or older, have been diagnosed with colorectal cancer, and are planning to undergo bowel resection with an expected inpatient stay of at least 3 days. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention or a usual care group. Participants allocated to the intervention will be asked to access the RecoverEsupport website to complete online activities, learn about pre- and post-surgery behaviours, and access behaviour change strategies to enhance their recovery. Participants and clinicians will also receive prompts (e.g. SMS or email) to support adherence to Enhanced Recovery After Surgery (ERAS) recommendations. This intervention will occur from 2 weeks before surgery, to 3 months after surgery. Those participants who are randomised into the control group will receive usual care. Questionnaires will be collected at baseline, post-surgery, 1 months and 3 months after surgery. It is hoped this intervention will facilitate improved implementation of ERAS, and improve patients' recovery from surgery.

Chronic hip pain is a highly prevalent condition that is largely due to osteoarthritis (OA). Hip OA affects around 40 million people globally and is a leading cause of years lived with disability. With an ageing population and rising rates of obesity, the condition is projected to increase by 58% in Australia over the next decade, leading to substantial societal and health care burden. As hip OA has no cure, advice on self-management of symptoms is recommended as a core treatment component for all patients with hip OA. Currently, footwear guidelines for people with hip OA are based solely on expert opinion, and no research has investigated which type of shoes are most effective at reducing symptoms in people with chronic hip pain. We are conducting a research study to compare two classes of readily available off-the-shelf shoes on individual's self-reported hip pain. To do this, we will allocate people via a random process into two different groups. Participants in each group will be provided with 2 pairs of different shoes to wear daily for 6 months. To ensure that this is a fair and unbiased evaluation, we will not disclose the differences in the shoe classes between the two groups until the end of the study. There will be an equal number of participants in each group, and participants will not be able to choose which group they are in. The findings of this study will help determine which shoes are best for people with chronic hip pain and will guide clinicians in providing appropriate evidence-based footwear advice for their patients. The findings of this study will be published in medical journals and be presented at conferences.