ANZCTR search results

The study will determine the effects of 12 weeks treatment with the 'long-acting' glucagon-like peptide-1 (GLP-1) agonist, semaglutide once weekly (QW), on the rate of stomach emptying, glycaemia, blood pressure (BP) and heart rate (HR) following a standardised mashed potato meal, in type 2 diabetes (T2DM). The study will also assess the effect of cessation of semaglutide on gastric emptying at 1 and 4 weeks post-cessation. This is a randomised parallel designed study. Subjects recruited into the study who pass screening criteria will be randomised to receive semaglutide QW or matching placebo. They will have a gastric emptying study performed using the gold standard technique (scintigraphy) at baseline, at 12 weeks, and 1 and 4 weeks post cessation of semaglutide QW. Immediately following the first gastric emptying study they will commence treatment with semaglutide QW or Placebo, administered subcutaneously at weekly intervals. Glucose absorption, blood pressure, blood glucose and plasma insulin will be assessed during each of the gastric emptying measurements.

Failure of the upper oesophageal sphincter (UOS) relaxation is frequently observed in Parkinson's Disease. It contributes to swallowing dysfunction which has enormous impact on quality of life and is an important risk factor for life-threatening aspiration pneumonia. The randomized controlled trial aims to determine the efficacy of a novel, minimally invasive endoscopic myotomy of the cricopharyngeus muscle (C-POEM) as a treatment for swallowing dysfunction attributable to failed upper oesophageal sphincter relaxation. Participants will undergo baseline assessments including pharyngeal high-resolution impedance-manometry (P-HRM-I) to confirm a diagnosis of UOS dysfunction. Participants with P-HRM-I features of failed UOS relaxation will be randomised to receive either: 1) C-POEM (treatment group) or 2) swallow therapy guided by a speech pathologist (control group). At 12 weeks following randomisation and completion of assigned treatment, participants from both arms will undergo repeat evaluation, including: patient-reported outcome questionnaires, P-HRM-I, videofluoroscopic swallow study and clinical outcomes. Participants in the control group who do not respond to dysphagia therapy will be offered a cross-over to undergo C-POEM.

Kidney transplantation improves the survival and quality of life of people with end-stage kidney disease (ESKD) compared to remaining on dialysis. One of the major barriers preventing some people with ESKD from receiving a transplant is the presence of antibodies against a broad range of HLA antigens found in the community. Transplantation in the presence of antibodies directed against the HLA type of the donor (donor specific antibody, DSA) is associated with an increased risk of antibody-mediated rejection, development of transplant glomerulopathy and graft loss. To minimise this risk, many deceased donor kidney transplant allocation systems allow potential recipients to avoid donors with HLA antigens to which the recipient has detectable antibodies. There is therefore an unmet need for a strategy to reduce the number of HLA-specific antibodies in these highly sensitised patients. This study will specifically investigate whether Clazakizumab is effective at reducing HLA antibody levels, whether this allows some HLA types to be removed from the list deemed unacceptable and whether this increases the chance of transplantation. It will also study the safety of this intervention and the outcomes of the transplants performed.

We have highly effective psychological therapies for post-traumatic stress disorder (PTSD), however, individuals face multiple barriers to receiving gold-standard treatments. Most prolific of these is long waiting times, due to the limited number of professionals trained in specialist PTSD treatments. Here, we aim to evaluate a simple, digital, memory-based program MemFlex, which has been demonstrated to improve PTSD symptoms, and ameliorate cognitive difficulties that predict prognosis and impede the efficacy of psychological therapy. It is expected that offering MemFlex to individuals on the waitlist for psychological therapies will improve both a) cognitive predictors of PTSD, and b) post-treatment symptoms, relative to waitlist as usual.

A first time in human study to evaluate safety, tolerability, and pharmacokinetics of SIR2501 tablets compared with placebo in normal healthy adult participants. A single and multiple-ascending dose study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SIR2501 n healthy adult participants. Results of this study will inform dose selection and design of studies to assess the efficacy and safety of SIR2501 in neuropathies and neural degenerative disorders.

We are yet to fully understand which women are more likely to suffer pelvic floor (PF) trauma and dysfunction. The aim of this study will be to determine if there are pre-existing conditions that predispose women to prolonged second stage or instrumental births which ultimately leads to PF trauma and dysfunction. We would like to create an evidence-based screening questionnaire to identify women and track their birth outcomes. The screening questionnaire would be completed at their initial midwifery appointment. North Canberra Hospital are collaborating with experienced academic staff at the University of Canberra in the design of these projects to ensure high-quality research can be achieved and published in reputable journals to influence international practice. This information will be relevant to women’s health services around the world.

This is a prospective randomized controlled trial (RCT) comparing outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction (ACLR) with or without concomitant iliotibial band tenodesis. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period. This will include a range of patient reported outcome measures (PROMs), objective measures including anterior knee laxity, knee range of motion (ROM), peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength, and single limb hop capacity.

There is currently no gold-standard fistula-in-ano management that consistently achieves healing while avoiding faecal incontinence. Reported success varies in the literature. This study is a prospective, multicentre, randomised control trial to compare the safety and efficacy of cutting seton with ligation of the intersphincteric tract (LIFT) for complex cryptoglandular (primary) fistula-in-ano. Other outcomes examined will include development of faecal incontinence, and patient satisfaction. We aim to determine whether these procedures are equivalent in terms of ability to achieve complete fistula healing without developing significant faecal incontinence

High-Intensity Multimodal Training (HIMT) has recently gained interest as a proposed time-efficient method of meeting physical activity guidelines. Previous studies have demonstrated positive effects of HIMT on physical health and perceptual outcomes. However, the magnitude of these effects in HIMT remains unclear when compared to other methods of combined aerobic and resistance training (i.e., inter-session concurrent training [CT]). This may be due to a lack of standardisation in the prescription and reporting of training variables in HIMT. Therefore, the purpose of this study is to compare the effects of 7-weeks of HIMT and inter-session CT (on separate days to match physical activity guidelines) on physical and perceptual responses. This study will also compare physical activity behaviours prior, during and following the intervention.

Research has identified that over one third of young people with Type 1 Diabetes (T1D) experience disordered eating behaviours or at risk for an eating disorder (ED), which can impact T1D management and lead to diabetes-related complications and death. The current study aims to determine whether participating in the ADBP will reduce ED risk factors, depression, anxiety, and distress, and improve body acceptance, T1D management, and quality of life. This Randomised controlled trial will recruit 80 females with T1D between the ages of 15 and 25. Participants will be randomly assigned to an active control (educational videos) or the ADBP, which includes attending 6 weekly, hour-long, online group sessions that discuss body ideals and diabetes concerns. Validated surveys measuring body dissatisfaction, body ideals, disordered eating, quality of life, and diabetes distress, along with biometric data to assess diabetes management, will be collected at baseline (immediately prior to ADBP), immediately post-ADBP, and at 3 months follow-up. We expect that participation in the ADBP will lead to improvements in disordered eating, body acceptance, quality of life, and diabetes management