ANZCTR search results

This study will look at a patient-specific, remotely monitored, dose measured cycling exercise program following knee surgery. This new method uses a remotely-monitored bicycle power meter in order to prescribe and modify an exercise regimen. We hypothesize that patients who complete a patient-specific cycling exercise program following this surgery will have better short- and long-term outcomes than those who complete a non-cycling post-operative program.

Complications of MPS I include pain and functional symptoms. The aim of the study is to assess the safety of the investigational product pentosan polysulfate (PPS) in patients with MPSI, and to determine if PPS can successfully alleviate pain and functional symptoms in MPS I patients who have received ERT and/or haemopoietic stem cell transplantation (HSCT). Up to 10 participants (males and females aged 5 years or greater who meet the inclusion criteria) are expected to be enrolled. This is an open label study, in which participants will be sequentially assigned to receive either 0.75 mg/kg or 1.5 mg/kg of PPS via subcutaneous injection. PPS will be administered weekly for the first 12 weeks and then every second week until the end of the study. The study will run for 73 weeks from baseline. Following the screening visit, the participants will be required to attend the hospital for assessments out to week 73. Many of the scheduled visits may occur at the patient’s home by a member of the study team. There will be a final study visit involving assessments 5-7 days after the last PPS administration. There will be a final study visit involving assessments 5-7 days after the last PPS administration.

Posttraumatic stress disorder (PTSD) is the most common psychiatric disorder that develops following exposure to a traumatic event, such as interpersonal violence, combat, life-threatening accidents, or natural disasters. It is characterised by severe and persistent stress reactions including: intrusive memories and nightmares of the trauma, hypervigilance, difficulty sleeping, emotional withdrawal, pervasive negative emotions, and avoidance of places, activities, and situations that are reminiscent of their trauma. The treatment of choice for posttraumatic stress disorder (PTSD) is trauma-focused psychotherapy. Trauma-focused psychotherapy typically commences with psychoeducation about the trauma responses, and then focuses on three major strategies: anxiety management, exposure, and cognitive restructuring. Despite support for this therapeutic approach, meta-analyses indicate that at least one-third of patients do not respond to this treatment. Whilst extant treatments have shown success in reducing negative affect, they have had limited effect on increasing positive affect.This may be because extant treatments have focused solely on addressing symptoms reinforced by the withdrawal/defensive system and ignored the need to increase approach/appetitive responding, that results in increased positive affect. Modifying TF-CBT to include strategies that specifically target the approach/appetitive system may address a gap in available treatments that fail to address symptoms of dysphoria and anhedonia. Positive Affect Training aims to restore positive moods in participants alongside traditional extinction learning which reduces over-activation of the withdrawal/defensive motivation system associated with negative affect. To address the gap in augmenting the benefits of TF-CBT, this trial aims to test whether modifying TF-CBT to augment it with strategies to address anhedonia via Positive Affect Training will result in greater treatment gains relative to TF-CBT.

This study aims to determine the possibility and to examine if a short- term pelvic floor rehabilitation program can improve bowel issues after bowel cancer surgery with or without radiochemotherapy. Who is it for? You may be eligible for this study if you are an adult experiencing bowel issues after surgery for colorectal cancer. Study details Participants in this study will receive: 1. Education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises. 2. A 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strength training with use of an non- invasive technique called transperineal ultrasound for visual biofeedback, and anorectal sensory and coordination retraining using an minimally invasive technique called rectal balloon catheter biofeedback. Participants will also be instructed to practise home exercises and to complete a daily pelvic floor exercise diary. It is hoped that this research will determine the possibility of a short-term pelvic floor rehabilitation program for patients with bowel dysfunction after colorectal cancer surgery and treatment in an outpatient setting as well as identify the signals of benefit of pelvic floor rehabilitation for the improvement of bowel function and quality of life.

Exercise intolerance is a major cause of morbidity and a predictor of mortality in patients with heart failure (HF). Although many patients with HF have a dilated left ventricle and reduced ejection fraction, approximately 50% of patients have clinical manifestations of HF with a normal sized heart and normal systolic function. As such, HF is now categorised as reduced (HFrEF) vs preserved (HFpEF) ejection fraction. An important distinction of HFpEF patients is that traditional pharmacological therapies used to treat HFrEF have not improved quality of life or survival. There is currently limited understanding of HFpEF pathophysiology, thus there is a need for investigations that will lead to novel therapeutic approaches in the treatment of this condition. It is now appreciated that leg muscles become dysfunctional in HF, and generate an abnormal neural signal (a 'metaboreflex') that disrupts cardiovascular and respiratory control, enhancing ventilation and breathlessness, causing exercise intolerance (EI). A similar metaboreflex occurs within respiratory muscles, which reduces blood flow to the active limbs in these patients, exacerbating the metaboreflex arising from the legs in a detrimental positive-feedback manner, hastening the onset of breathlessness and EI. However, no studies have directly compared this reflex physiology in HFrEF and HFpEF. This proposal aims to identify metaboreflex contribution to EI by determining if the leg and respiratory muscle metaboreflexes contribute equally to EI in both HFrEF and HFpEF, their influence on cardiac function, and if exercise training attenuates metaboreflex signalling. The outcomes of this proposal will have clinical relevance and lead to the development of novel therapeutic interventions, through a combination of exercise prescription and pharmacological targeting of the metaboreflex in the early stages of HF and may lead to an elusive therapy that will improve quality of life and survival in patients with HFpEF.

Anterior Cruciate Ligament (ACL) reconstruction is an ever evolving subject. Significant improvements have been seen for this procedure over the past few decades, yet we still have high complication rates in the general population. Loss of extension post reconstruction has been reported as having an incidence as high as 59%. A loss of more than five degrees of extension can cause significant gait abnormalities, patellofemoral pain (pain behind the knee-cap) and quadriceps weakness. This in turn can affect the patient's confidence in returning to full activities. There are several causes of loss of extension post ACL reconstruction. The factor that will be assessed in this project will be the angle of the knee during graft fixation intra-operatively. Traditional orthopaedic teaching dictates tensioning the graft with the knee positioned between 20-30 degrees. There has been increasing evidence (mainly in biomechanical studies conducted in cadavers) that demonstrates over-constrained knees when the graft is tensioned in a flexed knee instead of a fully extended knee. This study aims to quantify the loss of extension associated with tensioning the ACL graft in a flexed knee. Patients that are undergoing ACL reconstructions will be included. In these patients we will assess their range of motion in both knees before the operation. During the operation the range of motion of the operative knee will be re-assessed using Computer Navigation for accuracy and reproducibility, The graft will be fixed on the femoral side and temporarily locked on the tibial side whilst the knee is in flexion. Then the knee will go through a full range of motion arc and measurements will be recorded. The graft will then be permanently fixed whilst the knee is in extension and the same motions and measurements will be undertaken. The anterior-posterior and rotational laxity of the knee will also be measured at the end of the operation.

Obstructive sleep apnoea (OSA) is a sleep and breathing disorder characterised by repetitive closure or narrowing of the airway during sleep. The upper airway muscles play an important role in keeping the upper airway open. In addition to the non-respiratory functional tasks of speech and swallowing, they serve an important role in tongue protrusion, airway stiffening/support and dilation during breathing. Conversely, poor upper airway muscle function plays a key role in the pathophysiology of OSA. Indeed, more than 30% of patients with OSA have minimal activation of the upper airway muscles during airway narrowing and closure during sleep. Although recent studies highlight the potential of oropharyngeal muscle training as a non-invasive approach to therapy a major unresolved question is: how does oropharyngeal exercise training improve upper airway muscle function to reduce OSA severity? To answer this question, the current study will evaluate changes in OSA severity and upper airway physiology following an upper airway muscle training protocol.

The receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies. The study will be conducted in two stages: phase I and phase II. Phase I will include healthy adults aged 18 - 45 years and evaluate the safety and immunogenicity reported after two-doses of vaccine when compared with placebo. Phase II will include a separate group of healthy adults participants aged 18 - 79 years and evaluate the safety and immunogenicity reported after receiving a single dose or two-doses of vaccine 28 days apart when compared with placebo.

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed by a multiple ascending dose (MAD) part (Part 2). Part 1 consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part 2 is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers

This study is a three-arm randomised control trial of an online intervention to reduce alcohol consumption in middle-aged women. The underlying theory for the intervention is based on the assumptions of the Integrated Behavioural Model (Fishbein, 2000) and the Transtheoretical Model of Change (Prochaska, 1979). Participants in the intervention will have access to core features that include goal setting, tracking of alcohol consumption, four modules of content, and associated challenges to operationalise their learnings. Participants will also complete Ecological Momentary Assessments (EMA) to record their alcohol consumption twice weekly over a 6-week period. We hypothesise that by the end of the intervention, participants in the online intervention group will report a significantly lower alcohol consumption than participants of the control group without weekly assessment (H1a). We also hypothesise that by the of the intervention period, participants in the online intervention group will display significant increases in; their awareness of harms associated with alcohol consumption (H2a), their motivation to reduce their alcohol consumption (H2b), social support (H2c),and current health status (H2d); and significant decreases in alcohol-related harm (H2e) and current level of stress (H2f), when compared to the control group without weekly assessment.