ANZCTR search results

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.

Therapeutic drug monitoring (TDM) is recommended for anti-tuberculosis (TB) drugs. Some drugs can penetrate into saliva and urine sufficiently enough to be used as alternative sampling. Our primary aim is to develop a salivary pharmacokinetic model for levofloxacin. The secondary objectives are to study the salivary penetration ratios for TB drugs, determine the relationship between the genotype of NAT2 and isoniazid level, and determine the feasibility of using saliva or urine for TDM. A prospective, open-label, observational study will be conducted in 30 adult patients receiving TB drugs. Plasma, saliva, and urine samples will be collected around week 2 for drug analysis. The population PK model will be developed using Nonlinear Mixed Effects Modeling (NONMEM®). Expected outcomes include a salivary pharmacokinetic model for levofloxacin, the relationship between NAT2 genotype and isoniazid level, and an assessment of the feasibility of using saliva and/or urine for TDM of TB drugs.

This project aims to examine the efficacy, feasibility and acceptability, of an emotion-focused cognitive therapeutic intervention, Imagery Rescripting, in improving clinical symptoms for individuals with generalised anxiety disorder (GAD). It is expected that a 10-week individualised Imagery Rescripting intervention will produce reductions in clinical symptom severity among individuals with a primary diagnosis of GAD. The research questions that this study seeks to address are: 1. Do individual participants with GAD report benefits of participation in Imagery Rescripting? 2. Is the intervention acceptable to clinicians and participants? 3. Are participants or clinicians likely to report any harms or adverse events associated with delivering Imagery Rescripting among individuals with GAD? 4. What types of mental images do participants with GAD describe during Imagery Rescripting, and how are these images thematically related to their current worries? 6. What are the estimated recruitment and retention rates during the intervention and follow-up periods?

The aim of this study is to test the feasibility of technology-assisted dietary assessment and advice to improve overall diet quality in patients awaiting elective cardiac surgery.