ANZCTR search results

Pregabalin and gabapentin are two medications commonly used to treat neuropathic pain. While both are moderately effective, there is significant variation between individuals, with patients often responding to one medication but not the other. N-of-1 trials are clinical trials that study a single patient, facilitating personalized data collection and reporting. We hypothesize that N-of-1 trials are a feasible method of comparing between pregabalin and gabapentin for individual patients with neuropathic pain.

This is a prospective, randomised, openlabel, activecontrolled, multicenter trial comparing treatment effects of CAM2038 (BPN depot injection) with BPN standard of care (for example, sublingual [SL] BPN or BPN/naloxone [BPN/NX]) in adult outpatients with opioid dependence. Opioid dependent patients who are either currently receiving medication assisted treatment (MAT) with SL BPN or BPN/NX, or patients who are actively seeking BPN standard of care treatment but who have not yet begun a treatment regimen, may be eligible for the trial. Patients will be randomised in a 1:1 ratio to either CAM2038 (involving either weekly or monthly depot injections based upon prescriber and patient choice) or BPN standard of care MAT. Stratification by new to treatment will be applied. The trial will consist of a Screening Period of up to 4 weeks duration, a Treatment Period of 24 weeks duration, and a Followup Period of 2 weeks duration. Outcomes relevant to study include the treatments’ perspective impact on patient’s satisfaction of treatment and other patient reported outcomes (PROs), as well as understanding the potential health economic impact and resource utilization with CAM2038 treatment.

After undergoing Carpal Tunnel release surgery, Peninsula Health patients currently are provided with a written leaflet developed by the hand therapy team at their first post-operative appointment. This is usually 10-14 days post-surgery. It is possible that patients may recover faster if they also receive a face-to-face consultation with a hand therapist, however there is only low level evidence from a retrospective case series study (Mack et al., 2017) to support this. We propose to complete a pilot study to see whether a randomised control trial would be feasible at Peninsula Health. The pilot study will take place over a 3 month data collection period, which is predicated on research honours student availability. Based on 2017 data, it is anticipated that the study could recruit a minimum of 20 patients (note: the original target of 50 was revised due to a downturn in the number of surgeries performed at this site, and a reduced recruitment period due to changed student project parameters). In this pilot study, participants will be randomised to two groups: 1: control group who will receive usual treatment (written information provision) 2: treatment group who will receive usual treatment plus one face-to-face hand therapy appointment We aim to collect data pre-operatively and then on three occasions over a 12 week timeframe: initial post-operative phase (10-14 days after surgery), 6 weeks and 12 weeks. Patient-rated outcome measures will include the Boston Carpal Tunnel Questionnaire; Quality of Life (using the EQ-5D-5L) and patient satisfaction with their recovery. We will also report on any complications such as Pillar Pain, infection and wound breakdown. Participants will be offered the choice of paper, on-line or phone-based completion of these measures. We will also conduct a basic cost-benefit analysis using utility scores calculated from the EQ-5D-5L and information regarding time off work and other health resource usage.

The overall aim of the project is to explore the communication between bone and muscle in older-adults over the age of 60years and, whether older-adults with or without low muscle function respond differently to acute-exercise. We will explore how different type of exercise affect bone and muscle metabolism as well as identify potential targets for future treatments tp prevent muscle loss associated with ageing. The intervention include three studies: study 1: a cross-sectional study to explore the characteristics of older-adults with and without low muscle function. Study 2: Utilising a resting muscle sample, this study is an in-vitro cell culture study where we will grow the sample in the laboratory and then treat the sample with different drug treatments to examine directly how the muscle responds. Study 3: is a randomised, cross-over, controlled trial to examine responses to acute exercise under three different conditions: aerobic cycling exercise, resistance exercise (including leg press and jumping) and control (complete rest). This study will include blood sampling at rest and following exercise. In addition, optional muscle sampling after each condition will help us to examine the direct effect of the different exercise modes at the muscle. This project is important as a limited information on older-adults is available. This study will generate novel knowledge as it has the potential to identify new communication pathways between the bone and muscle with implications for future drug targets and the management of sarcopenia or sufferers at risk of/with reduced muscle function.

The risk of pre-eclampsia (elevated blood pressure in pregnancy) can be predicted through a screening test at 11-13+6 weeks' gestation. Previous work has shown that 'high risk' women benefit from taking aspirin through their pregnancy - resulting in a 62% reduction in pre-eclampsia prevalence before 37 weeks. Current treatment does not alter the prevalence of term pre-eclampsia (i.e. after 37 weeks). This study will test whether adding another treatment (esomeprazole) will cause a further reduction in blood pressure at the end of pregnancy. Pregnant women will take one esomeprazole or placebo tablet each day from before 16 weeks until delivery, in addition to aspirin, and will have their blood pressure measured throughout the study.

In this study we aim to test a tool that has been designed for incentivising and educating vaccination among the school age population. The primary outcome will measure return rates of consent forms of those incentivised to do so with the collection of the vaccine card game ‘Vaxcards’. Secondary outcome measures will assess the effectiveness for the tool to increase knowledge and move attitudes towards behaviour change among school age vaccine recipients and their parents. We hypothesise that consent form return rates for community school vaccination will increase to those offered a pack of vaxcards. We also hypothesized that children and parents who receive a pack of vaxcards will show improved knowledge, attitudes and behaviors towards vaccination

Study RCT of Meaning & Purpose Therapy in advanced cancer The purpose of this study is to examine the effectiveness of the ‘Meaning and Purpose Therapy’ (MaPT) program in promoting psychological wellbeing and lessening psychological distress. Who is it for? You may be eligible for this study if you are aged 18 or over and have advanced cancer (of any type) with a prognosis of 2 years or less. Study details Participants will be randomised (by chance) into one of two groups. One group will continue their usual cancer care. The other group will undergo six sessions of counselling in the form of Meaning and Purpose Therapy with a mental health clinician in addition to their usual care. Each session will last for an hour and sessions will be conducted once per week. All participants will complete a number of questionnaires, firstly at the beginning of the study, then after 6 weeks (or on completion of the intervention) and finally 12 weeks later. It is hoped this research will improve wellbeing by helping participants to better appreciate life, including new possibilities, choices and goals, better morale and overall improvement in their quality of life.

This research aims to compare the effect of rapid versus slow fluid therapy in ICU patients with severe infection. In this study, we plan to randomly allocate 68 critically ill ICU patients to receive either rapid or slow fluid infusion therapy and measure parameters associated with blood circulation. We hypothesize that slow fluid therapy will lead to a greater increase in overall output from the heart, blood pressure, as well as other indicators of blood volume expansion,compared to those after rapid infusion.

The purpose of this study is to examine the feasibility and safety of a device for ablating cancerous lung tumors using a technique called thermal vapor ablation. Who is it for? You may be eligible for this study if you are aged 18 or older and are a suitable candidate for resection of a lung cancer tumor. Study details All participants will receive one treatment of thermal vapor ablation via a bronchoscope (tube down the throat), 2-4 days before undergoing their scheduled surgical lung resection. The treatment takes place under general anaesthetic in a day surgery procedure area. All participants will be followed-up using standard hospital procedures. It is hoped that this research will provide information into the non-surgical treatments of lung cancer, thereby providing future non-surgery related options for the disease.

Emerging evidence of preclinical studies suggests that bitter substances in the gut can reduce appetite and slow the emptying of meals from the stomach, by stimulating GI hormone release. The purpose of this study is to determine the importance of the region of small intestine exposed, and the role of bitter taste signalling, to the release of GI hormones and energy intake responses in both health and T2DM. we wish to investigate whether the non-nutritive bitter taste flavouring, denatonium benzoate (DB), and the low-nutritive bitter taste amino acid, leucine, induce substantially more glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) secretion when infused into the ileum than the duodenum, associated with greater suppression on energy intake in both healthy subjects and patients with T2DM.