ANZCTR search results

Aims and research design The aim of this pilot study is to assess the feasibility of a randomised controlled trial aimed to improve sleep of patients with low back pain, using a hypnotic drug called Zopiclone, which is a currently available drug approved by the Therapeutic Goods Administration. Methods In accordance with recommendations for pilot studies this pilot will recruit thirty-two participants. Participants will have acute low back pain and a co-existing sleep disturbance. Participants will be randomly allocated to one of two study groups of equal sizes. Patients in both groups will be encouraged to continue with their usual care, one group will receive placebo, while the other group also will receive Zopiclone over the course of 14 days. Procedure Participants who have sleep apnoea or severe insomnia will be excluded. As this is a pilot study the primary aim of this study is to use the data obtained to refine recruitment, outcome measures and randomisation procedures for a larger trial. A secondary aim of this study is to estimate the effect of managed sleep on acute low back pain from the 95% confidence intervals. There have been no other studies to date that have evaluated the feasibility of controlling sleep as a way of improving low back pain. As this is a feasibility study the primary outcome measure has not yet been defined. The participants will be asked to complete a Pittsburgh Sleep diary and a numeric rating scale (NRS) to rate their average pain intensity daily for the first 14 days. During this time participants will be asked to wear an actiwatch overnight. The actiwatch measures movement during sleep and therefore it is an indirect measure of sleep quality. Participants will be asked to complete a Low back screening questionnaire and Global perception of change scale. These measures were selected because they are widely employed to assess persistence in low back pain. Psychological factors including depression and anxiety will be measured using the DASS. Participants will also be asked to rate next day effects using a Flinders fatigue scale and an Epsworth sleepiness scale. Conclusion. This trial aims to conclude whether or not it is feasible to do a large scale randomised placebo controlled trial.

The aim of this study is to investigate the efficacy of pregabalin against headache resulting from unintentional dural puncture in obstetric patients having epidural analgesia for labour and delivery. The primary question addressed is “Does pregabalin reduce the severity of post-dural puncture headache in postpartum women after unintentional dural puncture?” Our hypothesis is that oral pregabalin will significantly reduce the severity of post-dural puncture headache in postpartum women experiencing the complication of unintentional dural puncture. The question is addressed by conduct of a randomized, double-blind, placebo-controlled, parallel-group, superiority clinical trial. The study drugs will be commenced after unintentional dural puncture and patients followed for one week, with the incidence and severity of headache important outcomes showing whether pregablin is effective compared with a placebo.

People with schizophrenia can experience difficulties with attention, concentration and memory; these are referred to as cognitive symptoms. There are currently no effective treatments for these symptoms. We are investigating whether non-invasive brain stimulation, specifically transcranial Direct Current Stimulation (tDCS), is able to improve cognition in individuals with schizophrenia.

Hypothermia is a known adverse effect of general and regional anaesthesia. It is associated with increased risk of complications including surgical site infections and bleeding. For this reason, it is recommended that strategies are implemented to prevent hypothermia. The most effective strategy is forced-air warming. Of note, with advances in medical technology continuing to expand the indications for minimally invasive surgical techniques, sedation is likely to be increasingly used for many procedures that once could only be performed with general anaesthesia. Interventions to prevent hypothermia from occurring, such as forced air warming, are not currently used for sedated patients. Yet, we recently observed in one of our previous studies that about one quarter of patients undergoing procedures with sedation were hypothermic after their procedure. Sedated patients who become hypothermic may be at similar risk of developing complications, like infections and bleeding, to those patients who undergo a general or regional anaesthetic. As such, investigation of the clinical benefits of preventing hypothermia in sedated patients is required. This research aims to determine whether forced air warming reduces hypothermia in sedated patients. The results could potentially benefit the large number of patients undergoing interventional procedures with sedation.

Lauricidin is an over-the-counter wellness agent, the active ingredient of which is glycerol monolaurate (GML), a naturally occurring inhibitor of production of a bacterial enzyme (a lipase) which breaks down lipids (fats). GML is found in coconut, milk and other foods and is classed by the FDA as Generally Regarded as Safe (GRAS). Lauricidin is sold as a skin cream containing 1% glycerol monolaurate. The purpose of this study is to determine the ocular safety (as measured by ocular redness, ocular staining and discomfort) of lauricidin moisturising cream in a normal population when applied around the eyelids, and the efficacy of the cream when used by dry eye disease participants for the treatment of dry eye. Efficacy will be determined using a number of clinical measures comprising Ocular Surface Disease index (OSDI) score, tear break up time and collection of bacteria from the eyelid using lid swabs. Our hypotheses are that there will be no difference between lauricidin moisturising cream and petrolatum for eye redness, corneal staining and ocular symptoms during the safety phase and OSDI score, tear break up time and lid swabs during the efficacy phase.

The project is a naturalistic observational study of individualised Western herbal medicine in a naturopathic practice setting. This project will explore the effectiveness of individualised herbal medicine prescriptions in self-reported anxiety and depressions, using a whole practice framework. This approach will not only help to evaluate total herbal medicine practice as it is practised – rather than evaluate individual herbal medicines in specific conditions in a manner which does not reflect practice – but will also help to develop research capacity on the herbal practitioner community, who will be involved in the study.

The main aim of this study is to see whether pentosan polysulfate sodium (PPS) is safe and effective in treating Bone Marrow Oedema Lesion (BML) associated with acute knee injury and thereby relieving the pain caused by BML. Every person who participates in this study will receive a course of PPS injections.

This study will determine the safety and pharmacokinetics of the investigational drug RX108 in patients with advanced or metastatic solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with an incurable, locally advanced or metastatic solid tumour that has progressed or failed at least one prior systemic therapy or have refused systemic treatment. Study details All participants will receive the investigational drug RX108 through intravenous infusion at a low dose and will be escalated. Each participant will only receive a single dose, depending on the cohort into which they are recruited. The study will use an accelerated dose escalation design using single patient cohorts until a single related toxicity of Grade = 3 or a Dose Limiting Toxicity (DLT) is observed. Safety and tolerability of RX108 will be assessed by such as physical examination, vital signs, ECG, and clinical laboratory testing at 30 days and 7 months post intervention commencement. Maximum tolerated dose will be determined via the safety review committee (SRC) and Investigators review the optimal balance between the dose (pharmacokinetic (PK) parameters), toxicity and biomarker studies confirming target effect. Participants will be followed-up until 7 months post intervention commencement to investigate potential biomarkers for RX108.

The primary aim is to determine, over a 12 month period, the relative dental caries (tooth decay) arrest and prevention abilities on the primary teeth of children aged one to eight years of a once-only treatment of 38% silver diamine fluoride, compared to three-monthly applications of 5% sodium fluoride varnish in the Tasmanian clinical situation. The secondary aims are to compare: 1/ The dental caries prevention and arrest abilities of once-only treatments of silver diamine fluoride, silver diamine fluoride/potassium iodide, and silver diamine fluoride/potassium iodide/glass ionomer fissure sealant . 2/ The effectiveness as measured by relative cost, patient and clinician acceptability of treating tooth decay on the primary teeth of children of silver diamine fluoride, silver diamine fluoride/potassium iodide, silver diamine fluoride/potassium iodide/glass ionomer fissure sealant, and the standard dental treatment of restorations and extractions as determined by calibrated dentists if it were feasible to do the care under local anaesthetic.

Sepsis can occur when a person becomes unwell due to an infection. It is caused by inflammation throughout the body and affects the functions of organs such as the heart, lungs and kidneys. Sepsis can cause low blood pressure and impaired blood flow to the body’s tissues. This is sometimes called ‘septic shock’. First line treatment of septic shock is to give intravenous fluid to help restore the circulation. Standard guidelines recommend at least 30ml/kg initially, or approximately 2 litres in an adult. Often up to 5 litres is given in the first 6 hours. However, the volume required varies between individual patients, and calculating the correct amount can be difficult. There is emerging evidence that giving too much fluid can be harmful by leaking into the tissues (such as lungs), impairing organ function, delaying recovery and increasing the risk of complications. Other research suggests that giving excessive fluid affects the body’s immune responses. In particular this can lead to adverse effects on the normal function of small blood vessels within tissues. This may be one mechanism by which too much fluid leads to harm. An alternative means of restoring adequate blood pressure is to use a drug called noradrenaline. This is a chemical produced naturally by the body, which causes blood vessels to constrict, raising blood pressure. Noradrenaline, given by a continuous infusion through a drip, has been routinely used for decades for this purpose and is known to be safe and effective. Normally noradrenaline is commenced in patients whose blood pressure does not improve after 2-3 litres of intravenous fluid. While our current guidelines recommend initial generous fluid administration for septic shock, it has been suggested that using lower volumes of fluid may result in less inflammation and harmful effects, particularly on the cells which line the walls of blood vessels and control their function. This study aims to test this hypothesis. We propose comparing an approach where patients receive a smaller volume of fluid in their initial resuscitation, against the standard guideline-recommended volume. Participants will be randomised to one or other group. We will measure the blood levels of certain chemical markers of inflammation and blood vessel function. We aim to demonstrate that giving a lower amount of fluid in the initial resuscitation phase is feasible clinically, and results in less alteration of blood vessel function and inflammation in the body.