ANZCTR search results

A questionnaire, in three parts, will aim to assess students' and General Practitioners' knowledge, confidence and their attitudes to provision of undergraduate education on persistent pain management. The first section, relating to a case scenario of a patient with persistent pain will seek to elucidate students and GP's knowledge of the principles of persistent pain management, based on the International Association for the Study of Pain (IASP) proposals for an undergraduate curriculum. The second asks respondents to rate their confidence in components of the curriculum and the third asks for their views on the current provision of undergraduate education on pain management. Separate versions of the questionnaire will be tailored to apply to undergraduate students and to GP's.

BACKGROUND: Osteoarthritis (OA) is the most prevalent form of arthritis causing increasing pain, disability, reduced quality of life and economic burden worldwide. Its incidence is directly related to age with about 50% of the affected people aged over 65. Treatment for the disease is largely symptomatic with no established disease modifying interventions. Extracorporeal shock wave therapy (ESWT) is a physical treatment modality that has been shown to be effective in treating non-union of fractures and resolving a range of conditions associated with tendinopathy. Research in animal models suggests that ESWT may be effective in reducing the inflammatory and degenerative processes associated with osteoarthritis. AIMS: To evaluate the optimum lowest effective Focused-ESWT dose on knee OA related BML for efficacy and safety indications and to inform the design of a future randomised controlled trial (RCT). HYPOTHESIS: The participants who will receive the determined optimum Focused-ESWT dose will exhibit both clinical and biological improvements over the course of the study period. METHODS: Focused-ESWT will be delivered using the determined lowest optimal dose from a previous pilot study. The optimal dose will be determined based on the lowest dosage that demonstrates significant improvements in clinical and pathoanatmical changes based on imaging and biomarkers.

This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)of AND017 in healthy subjects. The study will involve two sequential parts: a single dose phase (SAD cohorts, Part A) followed by a multiple dose phase (MAD cohorts, Part B). Single doses of 1, 4, 10, 20, 30, and 50 mg AND017(n=6/dose) or placebo (n=2/dose) will be assessed in six consecutive cohorts of 8 subjects each in SAD cohorts (Part A) except Cohort 1 (4 subjects randomized at 1:1 to receive AND017 or placebo). Multiple doses of 4, 10, 20, and 30 mg AND017 (n=6/dose) or placebo (n=2/dose) will be administered daily for 10 days and assessed in four consecutive cohorts of 8 subjects each in MAD cohorts (Part B). Subjects will be fasted for at least 10 hours before administrating the investigational medicine with 240 mL water on dosing days. Subjects in SAD cohorts (Part A) will be inpatient for approximately 4 days with study drug administered on Day 1, and subjects in MAD cohorts (Part B) will be inpatient for approximately 14 days with study drug administered on Days 1-10. Subjects will be enrolled only in one study part and randomized to one cohort per the randomization schedule. For safety purpose, a sentinel dosing design will be applied in Cohort 1 (SAD cohort, Part A). The first 2 subjects will be dosed with one subject receiving AND017 and the other receiving placebo. After an interval of 48 h and review of all safety data of sentinel subjects, the remaining 4 subjects will be randomized at 3:1 to receive AND017 or placebo. There will be also a safety review (4 and 10 days in SAD (Part A) and MAD cohorts (Part B), respectively) before dose escalation for each cohort. Dose escalation will be stopped when predefined safety or pharmacodynamic criteria are met. This study allows some alteration from the currently outlined dosing schedule to reduce risk of subjects. Additional dosing cohorts may also be added to further evaluate the safety, PK and/or PD of AND017.

The Queensland Children’s Hospital has identified a need to determine if MCs are superior to PIVCs for patients requiring peripherally compatible intravenous therapy >4 days. Following an internal pilot to determine protocol feasibility we will undertake a randomised controlled trial (RCT) in children requiring administration of peripherally compatible intravenous therapy comparing current PIVC insertion to MC insertion with the primary objective to reduce catheter failure including dislodgement, infection, thrombosis, extravasation/infiltration, phlebitis, and occlusion. The secondary objectives are: 1. To compare PIVC versus MC in terms of the incidence of individual elements of failure (dislodgement, extravasation, infection, occlusion, pain, phlebitis, and thrombosis). 2. To compare insertion failure of PIVC versus MC. 3. To compare PIVC versus MC in terms of child and parent acceptability and satisfaction of the randomised catheter 4. To compare PIVC versus MC in terms of cost effectiveness in the acute hospital setting.

This research aims to collect outcome data from an individual treatment with supported self-help for school-aged children who stutter. The results will be analysed to identify what factors lead to successful and unsuccessful outcomes in school-aged children who stutter. These factors will be compared to existing data to create theories that can explain what factors create optimal outcomes in school-aged children who stutter. Stuttering can impact upon a child’s academic achievement and affect psychological, emotional and social well-being. Research into treatments for school-aged stuttering is limited. Treatment currently involves teaching fluency-enhancing skills to control stuttered speech and changing negative thoughts, feelings and avoidance behaviours associated with speaking. However, relapse after treatment is estimated to occur in 30% to 60% of clients, and increases with client age. Therefore, it is important to understand what factors are associated with successful and unsuccessful treatment outcomes to guide future speech pathology practice in the area of childhood stuttering treatments.

It is as yet unknown whether fluctuations in hydration status, such as those which may occur in a realistic heatwave scenario, may impact the efficacy of electric fan usage during heatwaves, and hence should be accounted for in future publicly disseminated advice surrounding fan use during extreme heat events. Therefore, the proposed study aims to examine the combined effect of hypohydration (reduced body water) and fan use during heatwave conditions. To achieve this, participants (n=16) will undergo four separate passive heatwave simulations within a climatic chamber (39 degrees Celsius, 50% relative humidity, 3-h duration). Both hydration status and the presence of an electric fan will be varied resulting in four scenarios: 1. Well hydrated, no electric fan used (EUH-NF) 2. Well hydrated, electric fan used (EUH-F) 3. Hypohydrated, no electric fan used (HYP-NF) 4. Hypohydrated, electric fan used (HYP-F) Throughout these four heatwave simulations we will monitor markers of thermal and cardiovascular strain as well as indices of hydration status and different heat transfer pathways such as sweating output. Manipulation of hydration status prior to the each exposure will be achieved via either 24 h of adhering to a fluid consumption plan (EUH-NF and EUH-F) or 24 h of fluid restriction (HYP-NF and HYP-F). We hypothesise that, the use of an electric fan will be beneficial (i.e. lower thermal and cardiovascular strain) during the 'well hydrated condition'; EUH-F compared to EUH-NF. However, in the 'hypohydrated' conditions (HYP-F and HYP-NF) this relation will be reversed, as hypohydration will cause a reduction in sweating output and therefore the mechanism by which electric fans augment heat loss will be compromised.

Clinical audit data suggests that electrical stimulation of the spinal cord is an effective treatment for chronic pain. but only a few high-quality experimentally-controlled studies of this treatment have been reported. We now wish to investigate effects of this stimulation on pain and associated symptoms (sleep and mood) in a double-blind randomised controlled trial. Specifically, we will compare pain and sensitivity to painful stimuli pressure and sharpness) while the stimulator is switched on and 3-4 days after the stimulator has been switched off. As BurstDR parasthesia free stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e , neither the participant nor investigator will know whether the stimulator is switched on or off). The therapeutic benefits of electrical stimulation will be evaluated in the patients own environment while they carry out their normal activities. The patient will monitor their pain, mood, analgesic consumption and sleep over 8 3-4 day blocks. The stimulator will be switched off during two of these blocks.

The primary aim of this study is to determine the feasibility of conducting an RCT of remifentanil versus fentanyl for opioid analgesic infusion in invasively ventilated patients who are expected to require mechanical ventilation for longer than 24 hours.

This study is seeking to create a representative data set on the current cannabinoid prescribing and dosage patterns in Australian clinical practice for a range of health conditions including cancer. Who is it for? If you are an adult who is already receiving medicinal cannabis therapy for your health condition, or you are seeking to receive medicinal cannabis and your doctor is able to prescribe medicinal cannabis as a treatment for your health condition, you may be eligible to participate in this study. Study details Participants will be asked to complete two different online questionnaire types on alternating months for a total of 12 months while they are taking specific prescribed medicinal cannabis products under the care of a CMOS participating clinician. Each online questionnaire may take between 5 - 25 minutes to complete. It is hoped that this study will allow clinicians and researchers to better understand how medicinal cannabis products are being used in Australian clinical practice and their potential benefit/harms as measured by reporting of side effects and patient satisfaction.

Septic patients often present renal dysfunction,, while it is important to figure it out the safety coverage and dose adjustment for these patients. This is a dose-adjusted, open-label, multi-centre study to determine the safety, tolerability and PK of STC3141 administered as a continuous IV infusion of up to 72 hours in subjects with sepsis and normal or compromised renal function in an ICU, where the rate of infusion is adjusted to account for calculated creatinine clearance. Four target steady state plasma concentrations (Css) are planned: 5µg/ml, 10µg/ml, 20 µg/mL and 25 µg/mL. Up to a total of 26 subjects will be enrolled into four (4) cohorts in the study, but numbers will depend on dose escalation/expansion decisions.