ANZCTR search results

This is a pre-market, prospective, single-site, open-label, within-subject, non-randomised interventional study of acceptance of the CP1175 and CP1110 Sound Processors through use with adult cochlear implant recipients in real world scenarios. The investigational medical devices include an off-the-ear sound processor, a behind-the-ear sound processor, used in conjunction with investigational versions of fitting software, the Nucleus Smart App and a software measuring postoperative implant function. The objectives of the investigation are to collect device and procedure-related deficiencies to optimise clinical care for recipients of the investigational CI1000 Series cochlear implants.

The aim of the present study is to investigate the effects of Brain and Body protein powder on sleep quality and other health-related outcomes—including cognition, mood, brain activity and biochemical parameters— in ageing adults 55-to-75 years of age. The Brain and Body protein powder may have the potential to affect benefits in the outcomes noted. This will be an 8-day randomised, double-blind placebo-controlled trial where 40 participants will be recruited. The trial will consist of two arms: 1) Dairy-based protein powder (Brain & Body Protein Powder) and 2) Rice starch placebo control.

This is a first-in-human, single-centre, randomised, double blind, ascending single dose study to assess the safety and tolerability of AP13 and how this drug acts in the body in healthy volunteers. AP13 may be indicated for use in patients with pulmonary hypertension, but a trial of the drug in healthy volunteers is needed before trials in patients with pulmonary hypertension can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of AP13 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with pulmonary hypertension.

This study aims to assess the safety and tolerability of a new tumour imaging agent in patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and have been diagnosed with locally advanced or metastatic melanoma. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. An 18F-FDG-PET and CT scans will be required for assessing participant eligibility, however if these scans were performed as part of standard of care prior to the date of consent but are within 28 days of the Day 1, they may not need to be repeated. Each participant's circumstances will be assessed by a study investigator and participants will be advised if scans need to be repeated. If eligible, participants will receive a single dose of 68Ga-A9T-3202 via intravenous injection, and then undergo 4 whole body PET-CT scans at set timepoints on the day of administration. Participants will then complete an End of Observation visit (one day post IP administration) to check participant safety and tolerability of 68Ga-A9T-3202. It is hoped this research will demonstrate that 68Ga-A9T-3202 is safe and well tolerated by patients with metastatic melanoma, and provide more accurate staging and treatment response evaluation when compared to the current standard of care PET/CT imaging.

The aim of this study is to examine whether intensive telehealth dietetic counselling, education, proactive medication management of nutrition impact symptoms, oral nutrition support +/- supplemental ('top-up') tube feeding into the small bowel will enhance quality of life for people with borderline resectable and inoperable pancreatic cancer having palliative chemotherapy, compared with usual care. Who is it for? Participants may be eligible to join this study if they are aged 18 years or above and have a new primary diagnosis of borderline resectable or inoperable pancreatic cancer. Participants will be randomised (allocated by chance) to one of two groups: usual care or intensive dietetics intervention (counselling, education, symptom management, oral nutrition support, +/- jejunal tube feeding if participant chooses) delivered via telehealth. For those randomised to intervention group, participants will receive the active intervention for 6-months, commencing as soon as possible after diagnosis. Personalised nutrition support/advice will be provided. Outcomes will be measured at baseline and at follow up at 3 and 6 months. It is hypothesised that this study will demonstrate effectiveness of early and frequent dietetic intervention and supplemental jejunal feeding (when required), in enhancing quality of life.

This is a combined drug treatment arm within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. The combination of gilteritinib and venetoclax will be evaluated for its activity in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details: The trial will commence with a safety run to determine the optimal dosing. Gilteritinib is given orally with or without food. Venetoclax is given orally after food. Venetoclax dose ramp-up is required only for patients commencing therapy with bone marrow blasts of greater than or equal to 5%. Each cycle will be 28-days in length Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Gilteritinib and Venetoclax will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The headset has in-built sensors that are able to track the movements of surgeons. There are specific patterns of movement that are associated with increased expertise. It is based on these specific patterns of movement that we aim to utilise to objectively assess surgeons. The project will involve surgical registrars and consultants performing operations as they normally would whilst wearing the motion-tracking headset. A transition to the operating theatre will allow us to further identify whether this headset can be used in a clinical environment and continue to provide objective assessment data. We aim to video tape the procedures to allow for further post-hoc analysis of the footage. We hope to use a headset that can tell us how efficiently a surgeon performs an operation to allow us to improve how we assess surgeons. We aim to use this technology to improve the surgical educational landscape by creating an objective method of assessing surgeons.

This multi-centre, prospective, tele-trial enabled interrupted time series trial will assess the feasibility, acceptability, and impact of pre-emptive, broad panel, pharmacogenomics testing and prescribing in patients with cancer commencing systemic anticancer treatment. This trial also aims to identify new pharmacogenomic dosing algorithms for medicines commonly used in the treatment or supportive care of cancer, and new pharmacogenomic variants associated with medication response or toxicity. Who is it for? You may be eligible to join this study if you are aged 18 years and older, are planning to receive systemic anticancer treatment, and have a diagnosis of gastrointestinal, breast or head & neck cancer, or diagnosis of Cancer of Unknown Primary, Hodgkin’s lymphoma or Non-Hodgkin’s Lymphoma. Study details Participants will be allocated to the intervention group or the control group depending on when they enter the study. All participants will undergo standard and discovery pharmacogenomic panel testing. Standard panel test results and dosing recommendations (based on panel results) will be provided to all participants and their clinician before commencement of anticancer treatment. Participants in the control group will receive dosing recommendations for Fluorouracil and Irinotecan. Participants in the intervention group will receive dosing recommendations for Fluorouracil, Irinotecan, and other commonly used medicines in the treatment or supportive care of cancer. If participants are receiving treatment with a ‘medicine of interest’ (i.e. netupitant/palonosetron, esomeprazole, morphine, oxycodone, fentanyl, irinotecan or sacituzumab govitecan), they may be eligible to participate in optional pharmacokinetic substudies assessing the relationship between medication exposure/response and pharmacogenomic variants. Participants will be followed up 5 times over a 12-week period. The first visit will occur within 30 days of commencement of anticancer treatment. Subsequent visits will occur 1 week, 4 weeks, 8 weeks and 12 weeks after anticancer treatment commencement. At each follow up visit, participants will complete questionnaires regarding symptom burden/toxicity and quality of life. The pharmacogenomics pharmacist will also take a medication history, assess symptom burden/toxicity, and provide advice on managing side effects from anticancer treatment. Participants who choose to participate in pharmacokinetic substudies will be asked to provide blood samples before and/or after medication dosing. It is hoped that this research project will show whether pre-emptive, broad panel pharmacogenomic testing and prescribing reduces adverse medicine events from medications commonly used in the treatment or supportive care of cancer. We hope to demonstrate that the pharmacogenomics testing and prescribing is feasible, acceptable and cost-effective within the Australian cancer care setting.

This multi-centre, prospective, tele-trial aims to evaluate the safety and efficacy of 5-Fluorouracil (5-FU) Therapeutic Drug Monitoring (TDM) in patients with metastatic/unresectable colorectal cancer. This trial will also assess the feasibility and acceptability of participants to conduct 'at-home' TDM self-testing. Who is it for? You may be eligible to join this study if you are aged 18 years and older, and are planning to commence infusional 5-FU-based chemotherapy that is used first-line or subsequent line (if being treated with irinotecan for the first time) for metastatic/unresectable colorectal cancer. Study details This is a sub-study of the PRECISION-ITS trial, all participants in this substudy will also participate in the primary PRECISION-ITS trial. In this substudy, patients will receive combined pharmacogenomics and TDM prescribing for 5-FU. Pharmacogenomic test results and dosing recommendations (based on panel results) will be provided to all participants and their clinician before commencement of chemotherapy. TDM test results and dosing recommendations will be reported by the pharmacogenomics pharmacist to the participant's clinician(s) in real-time before the next chemotherapy cycle. TDM will commence from the first cycle of chemotherapy and continue at consecutive chemotherapy cycles until target 5-FU drug levels are reached. At each chemotherapy cycle requiring TDM, participants will be asked to provide blood samples 3-17 hours and 18-40 hours after commencement of infusional 5-FU. The first sample will be self-collected by participants via finger prick blood collection devices, The second sample (consisting of finger prick and venous blood samples) will be collected by site staff. Participants will receive education from the pharmacogenomics pharmacist on how to conduct TDM self-testing and sample delivery. It is hoped that this trial will show that a combined pharmacogenomics/TDM prescribing approach for 5-FU increases treatment response to 5-FU based chemotherapy in metastatic/unresectable colorectal cancer, and that 'at-home', finger prick TDM testing by patients is feasible (thereby reducing patient burden for venous blood tests).

There is strong evidence that exercise reduces falls in older people. However, many older people do not do sufficient exercise to reduce their risk of falls. While there are programs and resources to support older people engage in exercise, these have predominantly been developed for people from English speaking backgrounds. The aim of this project is to work with older people from three culturally and linguistically diverse backgrounds to co-design an exercise and fall prevention program. The program will include specific strategies to support behaviour change and development of exercise habits, resources for older people from the three culturally and linguistically diverse groups and a training package/resources for health professionals. Key components of the developed intervention will be tested with 10 older adults from Italian, Chinese and Arabic speaking communities.