ANZCTR search results

This study aims to explore the use of exercise as an intervention to assist with the management of sleep disturbance in primary brain tumour survivors and their caregivers Who is it for? You may be eligible to join this study if you are aged 18 years and older and have histologically confirmed primary brain tumour (WHO Grades II-IV) Study details All participants in this study will have 2x telehealth sessions per week with an Accredited Exercise Physiologist who will prescribe each participant an individualised exercise program to conducted over an 8-week period. While the exercise sessions will be individualised, the general exercise prescription (e.g., frequency, intensity, time, type) will be consistent across all participants. Participants will also be prescribed individualised aerobic exercise program 2x per week on days that they are not performing their telehealth session. Participants may also be allocated an Oura Ring to wear throughout the study period as well as a 4 week calibration/baseline period prior to commencing the 8-week intervention period to objectively monitor sleep. Participants will be allocated an Oura Ring through an alternating system (i.e., every second participant recruited will be allocated a ring to wear) which will be provided to participants prior to their baseline testing session. Participants will also complete questionnaires to assess sleep quality, quality of life and mental health and functional outcomes will also be assessed before and after the intervention period. Semi-structured qualitative interviews will also be conducted pre- and post-intervention exploring each participants sleep experiences and their beliefs on what contributes to said experiences. It is hoped that this research project will contribute to the understanding of exercise's potential role in managing sleep disturbances for PBT survivors and their caregivers. By addressing the gaps in existing literature and collecting comprehensive data on sleep, quality of life, functional, and mental health outcomes, this study aspires to provide evidence-based recommendations for improving the well-being of individuals affected by primary brain tumors

This study aims to investigate whether the combination of FDG-PET imaging, and blood sampling will lead to more accurate assessment of anal cancer location and progression. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with anal cancer (specifically, anal squamous cell carcinoma) and your doctor has determined that chemoradiation therapy would be a suitable treatment option for you. Study details All participants who choose to enrol in this study will be asked to provide up to 3 blood samples which will be tested for cancer markers. Participants will also be asked to undergo a form of imaging called FDG-PET scanning which will involve injection of a dye prior to the scan. It is anticipated that completion of the scan and blood samples will take no more than 2 hours. Participants will be asked to complete 1 FDG-PET scan prior chemoradiotherapy, 1 FDG-PET throughout the course of their chemoradiotherapy which is usually delivered over 5-6 weeks and maximum of 2 FDG PET post chemoradiotherapy. It is hoped that the findings from this investigations will provide new cancer markers that can be used to determine how well patients with anal cancer are responding to chemoradiation treatment. If this study finds new markers that look promising, these may be used to guide treatment decisions and could lead to improved outcomes for patients with anal cancer.

Myocardial infarction (MI) affects ~57,000 Australians every year and almost half a million Australians have had a heart attack at some point in their lives. While mortality after MI has been declining over the last few decades, it is in the group of young patients that it has lagged. Data on the biological and pathophysiological factors related to MI in the young is scarce. In addition, there are gaps in quality of care due to the perceived risk for MI being low. The study aims to characterise the clinical presentation, risk factors, angiography findings, underlying aetiology, quality of care and sex differences, of young patients with MI (age <50 years). This is an investigator-initiated, observational, single-centre clinical registry study. Approximately 500 patients under the age of 50 years with MI will be recruited retrospectively from Westmead Hospital.

Future Health Today is a co-designed quality improvement technology platform for general practice. It has been developed by multiple professionals including general practitioners, practice nurses, non-GP specialists, researchers, and information technology specialists. The software integrates with standard practice software. This trial involves general practice using the chronic disease modules of chronic kidney disease, diabetes and cardiovascular disease. The modules flags patients are are at risk of or diagnosed with the chronic disease (for example kidney disease). It suggests evidence-based investigations, diagnosis for those meeting diagnostic criteria, and management. It also has links to evidence-based guidelines and patient education tools. Quality improvement projects can be completed at a practice level with the ability to recall patients needing further evaluation and management. Study investigators hypothesis that this intervention will improve the detection, diagnosis and management of chronic kidney disease in primary care.

This study aims to evaluate the safety and tolerability of a single ascending dose of CTX320 in patients with elevated lipoprotein(a) and a history of atherosclerotic cardiovascular disease or calcific aortic valve stenosis and to determine the recommended Phase 2 dose.

This non-randomised controlled trial seeks to determine the association between use of different hormonal contraceptives and the outcomes of a brief, cognitive behavioural treatment for claustrophobia in a sample of women with at least moderate claustrophobia symptoms. Treatment outcomes from women taking the combined oral contraceptive pill, and those taking progestin hormonal contraceptives (including the progestin only pill, the hormonal contraceptive injection, and the hormonal IUD) will be compared to those from women who are not taking hormonal contraceptives and have regular menstrual cycles. Changes in behavioural and self-reported claustrophobic symptoms will be compared between these groups from pre to post treatment (one week after treatment, and one month after treatment).

Performing exercise in an environment where the oxygen concentration in the air is lower than that of sea level (i.e. hypoxia) during exercise may mimic the metabolic responses of higher-intensity exercise, whereby a greater reliance on muscle glycogen utilisation occurs. It is therefore likely that the additional stimulus of hypoxia superimposed on a high intensity interval exercise will result in greater metabolic adaptations in the longer-term. That said, exposure to hypoxia may also lower mechanical work sustained during high intensity exercise. Therefore, it is unclear whether the application of hypoxia during exercise will enhance or interfere with the benefits of high intensity interval exercise. Accordingly, the aim of the current research is to determine if high intensity interval exercise in hypoxia (within the context of an exercise program including resistance exercise) enhances insulin sensitivity and glucose tolerance to a greater extent compared to a conventional training in normoxia in individuals who are sedentary and overweight.

This study aims to assess the safety and feasibility of Poly Aryl Ether Ketone (PAEK) Implant for Contour Restoration in Jaw Reconstruction in patients with (or without) head and neck cancer Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo jaw reconstruction Study details All participants in this study will have a jaw reconstruction using a Poly Aryl Ether Ketone (PAEK) contouring implant. Participants will have two appointments with the reconstructive surgeon prior to the reconstruction to get 3D optical facial scans and CT scans of the facial bones and fibula and intraoral scan of dentition (teeth). The PAEK contouring implant will be manufactured to match participant’s jaw contour using computer aided design and computer aided manufacturing. The PAEK will then be implanted permanently during the jaw reconstruction. Participants will be followed-up post-operatively for 12 months to assess safety, integration of implantation and quality of life in participants. It is hoped that this research project will improve the aesthetics of patients undergoing jaw reconstruction.

The SALAD Trial is a Randomised Controlled Trial assessing the effect of local anaesthetic delivered to the shoulder joint by a catheter inserted during surgery on post-operative pain control. Post operative pain relief makes patients more comfortable, can increase rate of recovery and reduce the risk of long-term dependence on opioid pain relief. The aim of this study is to see whether local anaesthetic delivered into the shoulder joint after surgery in addition to usual pain relief reduces pain compared to usual pain relief alone. This study is a collaboration between three departments at Royal Prince Alfred Hospital (RPAH): Department of Anaesthetics, Department of Orthopaedic Surgery, and Surgical Outcomes Research Centre (SOuRCe). All participants will undergo arthroscopic rotator cuff repair surgery followed by insertion of a subacromical cathether for the administration of local anaesthetic or placebo. The first dose of local anaesthetic or placebo is administered in the Post Anaesthesia Care Unit (PACU) as the pump is connected. Participants will be randomised to receive either local anaesthetic or placebo. We hypothesise that in patients undergoing primary arthroscopic rotator cuff repair procedures, there is a significant reduction in post-operative pain and opiate usage for patients who receive a Programmed Intermittent Bolus of Local Anaesthetic into the subacromial space via a subacromial catheter compared to patients who receive a placebo infusion into the subacromial space only.

This is a Phase I, randomised, double-blind, placebo-controlled, ascending dose study, with an adaptive patient arm. Healthy volunteers (HVs) and/or patients with Type 1 Diabetes will be enrolled and randomised to 6 cohorts: - Cohort 1: 6 partcipants randomised at a ratio of 2:1 (active: placebo) - Cohorts 2 to 6: 8 participants in each cohort at a ratio of 3:1 (active: placebo). SAB-142 is currently being developed as a disease-modifying therapeutic agent to delay the onset and progression of T1D. The purpose of this study is to test the safety of SAB-142 when given to healthy volunteers or Type 1 diabetes patients. The starting dose will be 0.03 mg/kg with 5 dose levels planned (up to 4.5 mg/kg). Dosing in each cohort will commence with two sentinel participants, with one of the two sentinels randomised to receive SAB-142 and the other randomised to receive placebo. The sentinel participants will be monitored in the clinic for at least 7 days and at least 3 days of available safety/tolerability data will be reviewed by the Safety Review Committee (SRC) prior to dosing the remainder of participants in each cohort. In the event that adaptive design criteria are met, dosing of HVs will cease, and the study will transition to an adaptive T1D patient part of the study. In this case, T1D patients will be enrolled and randomised (6 participants in each cohort, ratio 2:1 active: placebo). The starting dose for the T1D patients will be equivalent to the next dose level from the last dose administered to the HVs full cohort, or will be equivalent to the last dose level administered to the HVs if a transition to the T1D patients is recommended after the sentinel cohort. The decision to escalate between dose levels and proceed to the next cohort in HVs or to move to the adaptive T1D patient arm of the study, will be made by the SRC following review of available safety and tolerability data from Day 1 up to Day 14 for all participants in the cohort.