ANZCTR search results

Intracytoplasmic Sperm Injection (ICSI) was first described in 1992 and has since been routinely used to treat patients with severe male factor infertility with much success. An alternative method of injecting sperm into the oocyte has been described: PIEZO-ICSI. This utilises an actuator in piercing the zona pellucida of oocytes, which allows for microinjections with less physical stress being applied during the procedure. The hypothesis of this study is that using the PIEZO-ICSI technique to inject sperm will result in a higher fertilisation rate compared to conventional ICSI. This will be a sibling oocyte study in patients aged 38 and over.

Research suggests SGLT2 inhibitors may help people with type 1 diabetes by improving blood sugar control and supporting weight management. It is also possible that the heart and kidney benefits seen in people with type 2 diabetes may extend to people with type 1 diabetes. However, they are not approved for people with type 1 diabetes because there are important safety concerns. In people with type 1 diabetes, SGLT2 inhibitors can increase the risk of diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition. Although findings from our clinical trial (PARTNER) has shown that dapagliflozin (an SGLT2 inhibitor) can significantly improve blood glucose control and weight without DKA events with the use of a continuous ketone monitoring device, participants in the trial receive frequent monitoring and support from the study team, which may not reflect routine clinical practice. The aim of this study is to assess the safety of off-label Dapagliflozin use in adults with type 1 diabetes living in the community, supported by continuous ketone monitoring. We hypothesise that similar to the PARTNER study, there will be no DKA events.

The aims of this project are to pilot and test the feasibility, acceptability and efficacy of the RECONNECT ME program, specifically: 1. Examine the impact of the RECONNECT ME program on children’s screen time, wellbeing, social skills, thinking skills and family functioning 2. Explore what factors are associated with these (potential) changes (e.g. home environment, parent role modelling etc). 3. Explore the feasibility and acceptability of the RECONNECT ME strategies

SACHA is an international registry that collects information on innovative cancer treatments used for children and young adults aged 25 years or younger with recurrent or refractory cancer outside of clinical trials. These treatments may be used off-label or through compassionate access. The registry collects treatment and outcome data to better understand their safety and effectiveness in routine care. It is hypothesised that learning from these experiences will improve knowledge of these treatments and help inform future care and research.

This study will evaluate a digital literacy program for older adults aged 60 years and over with hearing and/or vision loss. Trained Digital Mentors will provide one-to-one support to help participants build their digital skills and confidence over 6–8 weeks. The study will assess whether the program is practical and acceptable and explore changes in digital confidence, skills, technology use, social participation and wellbeing. Participants will complete assessments before and after the program and again three months later. The findings will help improve the program and inform a future larger study.

This Phase 1 study is a randomized, placebo-controlled, double-blind, ascending dose, first in human trial of IN-007 vs. placebo in normal healthy volunteer men and women. The study will assess the safety and pharmacokinetics on IN-007. the study drug is being developed for the treatment of mild to moderate COVID-19. The study is designed to enrol normal healthy participants in Part A (2 cohorts) and Part B (2 cohorts) with each cohort testing a different dose and number of doses of IN-007. 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 8-9 weeks.

The aim of this research study is to characterise the acute physiological and exercise-endurance responses to two divergent passive lower-limb heating modalities (hot-water perfused trousers, and infrared leg heating) compared to knee-down water immersion in individuals with HF with reduced ejection fraction (HFrEF). Participants will be asked to visit Griffith University on up to four separate occasions. During the first visit, participants will be familiarised with the study procedures and equipment, and complete the incremental shuttle walk test. In the subsequent three visits (separated by a minimum of 5 days), conducted in a random order, participants will undergo 45 minutes of one of three different lower-limb heating methods: Placing your lower legs, up to knee height, in a circulating warm water bath (42°C); Wearing a pair of trousers through which warm water is circulated; Sitting with your legs positioned within an infrared heating device; and a control condition where no heating is applied. During all experimental sessions, participants heart rate, blood pressure, oxygen saturation, and cardiac output will be continuously monitored. Every 15 mins throughout heating, we will measure the size and blood flow of the the femoral artery using an ultrasound machine. Immediately after each heating session, participants will complete a walking test (the Endurance Shuttle-Walk Test) that measures how long individuals can exercise at a set pace, It is hypothesised that exercise endurance results will vary dependent on the magnitude of femoral artery blood flow increase at end-heating.

This study aims to assess the safety, practicality and participant experience of a non-invasive DermR® Patch for collecting samples from basal cell carcinoma (non-melanoma skin cancers) before surgical removal. Who is it for? This study is for adults aged 18 years and older with a dermatologist-diagnosed Basal Cell Carcinoma (BCC) in a suitable location and of a suitable size for secure patch placement. This small study will involve 10 adults who have been diagnosed by a dermatologist with Basal Cell Carcinoma, are scheduled to have the affected area surgically removed, are willing to undergo Patch sampling before surgical excision and permit research use of genomic data. Study details Before the participants' planned surgery, trained MoleMap staff will apply the non-invasive DermR® Patch to the affected area and to a nearby area of normal-looking skin. Two Patch applications will be performed on the target dermatologist-diagnosed BCC lesion and two Patch applications will be performed on clinically normal skin in the same body area. Samples will be labelled and shipped to a central laboratory for RNA quality assessment and molecular analysis. Participating in this study's procedures will not delay or alter standard clinical care. Participants will also complete a short experience questionnaire immediately after sampling. The application sites will be checked for any skin reactions. Any reactions or other relevant medical problems occurring within 24–72 hours after Patch application will be recorded. Relevant problems first identified or reported at the participant’s next routine clinical appointment will also be recorded. The laboratory findings will be used only to help develop the DermR® Patch and its associated test. The results will not be provided to participants or their doctors and will not be used to diagnose the skin lesion or change the participant’s usual medical care. It is hoped that the findings of this study will help determine whether the DermR® Patch is comfortable and acceptable to participants, whether it causes any skin reactions, and whether the samples can be safely handled and provide enough good-quality material for laboratory testing.

This study evaluated whether topical gentamicin 0.1% improves wound healing in people with epidermolysis bullosa (EB) caused by nonsense variants in the COL7A1 gene. In this randomised, double-blind, vehicle-controlled phase II pilot study, each participant had two similar wounds, with one treated with gentamicin and the other with an identical placebo for approximately 30 days. The primary aim was to determine whether gentamicin increased the proportion of wounds that achieved complete healing within 30 days and reduced the time to closure. Secondary outcomes included wound size, recurrence, infection, and patient-reported symptoms such as pain and itch. Safety was monitored through clinical assessments, laboratory testing, and hearing evaluations.

The purpose of this study is to find out whether Immersion Therapy can help reduce pain and improve everyday activities for people with chronic non-specific low back pain, the study also aims to assess the feasibility and acceptability of the intervention and the study design. Participants will complete a baseline period, receive Immersion Therapy sessions, and then complete follow-up assessments, including measures of pain, disability, physical activity and daily activity throughout. The findings will help determine whether Immersion Therapy and the study procedures are suitable for a larger future study. Lastly, at the end of the program, participants will be asked to share their thoughts, feelings, and experiences about IT sessions.