ANZCTR search results

An open-label study in healthy volunteers: To evaluate the safety, tolerability and pharmacokinetics of dapagliflozin (35 mg) extended release capsules (LYN-045) in healthy volunteers To characterize the pharmacokinetics (PK) of dapagliflozin (35 mg) extended release capsules (LYN-045).

The primary purpose of this study is to further compare and analyse dorsal plate vs transarticular screw fixation in Lisfranc injuries through a randomized controlled trial. The primary outcome is improvement of pain post-operatively, as assessed by the Manchester-Oxford Foot Questionnaire (MOxFQ) pain score. Secondary outcomes include, MOxFQ function score, EQ-5D quality of life score, AOFAS midfoot scores and need for further surgery, such as for fixation failure, pain secondary to metalwork and infection. Tertiary outcomes include monitoring for radiological signs of arthrosis/joint fusion. These outcomes have been selected to further examine the factors important to patient satisfaction, as well as the factors to likely require further surgery either acutely or in the future.

Delays in escalation of care (EOC) can have serious consequences for patient safety and patient outcomes. While initiating a Medical Emergency Team (MET) call is a relatively smooth process, there are no defined behaviours surrounding pre-MET conversations. Even with well-established protocols, clinicians are reported to experience factors that inhibit initiation of EOC conversations. Research has identified key barriers to initiating EOC conversations as: fear of hierarchy, respondents explaining away or dismissing concerns, and poor risk awareness or skills. The purpose of this project is to address some of the barriers involved in EOC conversations prior to a MET call. To do this, an intervention that provides clinicians with training on the expectations of the ‘initiator’ and the ‘responder’ during an escalation conversation (in the form of a ‘choose-your-own-adventure’ training video) will be trialled at Austin Health. The training will be evaluated using pre- and post-intervention questionnaires on clinicians’ knowledge, confidence, and reluctance to escalate patient care, and experience sampling will be employed to examine clinicians’ experiences of EOC conversations during the trial period.

This randomised controlled trial aims to investigate the efficacy and acceptability of telemedicine vs. traditional in-person follow-up for patients undergoing uncomplicated general surgical procedures. These general surgical procedures include appendectomies, umbilical and inguinal hernia repairs, and cholecystectomies.

Health professionals have long established a link between gum disease and cardiovascular disease. However, whether the treatment of gum disease reduces the risk of having a cardiovascular incident, for example- a heart attack, remains a question mark. Colchicine is a drug that has been shown to reduce cardiovascular risk. This trial aims to help ascertain whether a combination of gum disease therapy and colchicine therapy will reduce the risk of having a cardiovascular incident.

The aim of the National Breathlessness Survey is to evaluate respiratory symptom burden (breathlessness, cough, wheeze and/or chest tightness), treatment, healthcare utilisation and patient attitudes and beliefs in a randomly selected adult population, irrespective of any current diagnostic assignment. Specifically, the National Breathlessness Survey aims to: • Describe the prevalence (and severity) of breathlessness in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis, or cardiac disease. • Describe the frequency of breathlessness and the impact of breathlessness on quality of life in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis or cardiac disease. • Quantify how many people have exposure to known risk factors for developing breathlessness or experiencing adverse health outcomes of contributory conditions, including the presence of comorbidities (e.g. exposure to tobacco products, occupational exposure to fumes, dust and asthmagens, inactivity/obesity). • Assess healthcare utilisation among people with breathlessness.

To evaluate the safety of LYN-005 extended release capsules containing risperidone in patients with schizophrenia, schizoaffective disorder or bipolar 1 disorder. To perform characterisation of the the pharmacokinetics of risperidone and active metabolite, 9-hydroxyrisperidone, and active moiety administered as a LYN-005 extended-release (ER) capsule of risperidone to immediate-release (IR) risperidone tablets

An open-label, multi-centre study in healthy volunteers: To determine the safety and tolerability of LYN-157 when administered as a single dose to participants on steady-state daily memantine HCl and donepezil HCl. To characterize the pharmacokinetics (PK) of memantine HCl and donepezil when LYN-157 is administered as a single dose to participants on steady-state daily memantine HCl and donepezil HCl. To assess the effect of pre-dose food (i.e., fasted, low and high-fat meals) on memantine HCl and donepezil HCl PK following a single dose of LYN-157 to participants on steady-state daily memantine HCl and donepezil HCl.

Outcomes: The aim of the research study to explore the effectiveness of each of the treatment methods in reducing oedema in the hands following tetraplegia. The quantitative study will identify whether there was a reduction of oedema or not in this sample. The treatment methods will also provide a comparison of the two treatment methods to determine if there is a trend for one to exert a greater effect than the other. The qualitative study will provide findings from the participants’ perception of the oedema and oedema management and their impact on daily function. This aspect of the study will explore participants’ experiences of developing oedema and the management techniques, seeking to explore the potential impact of both on their day to day function.

A single arm feasibility study of an 12-week smoking cessation intervention consisting of varenicline, combination nicotine replacement therapy, and counselling (motivational interviewing) among men at risk or experiencing homelessness and attending a healthcare clinic. The primary aims of the feasibility study is to assess the safety of the intervention (as recorded by number of adverse events, serious adverse events). If the intervention is found to be feasible and safety for this population this intervention could be implemented as part of standard practice and a model for other healthcare clinics treating this high priority population for tobacco smoking.