ANZCTR search results

open label single arm self-controlled trial of the affect of 15 days of abacavir on platelet function in healthy HIV positive volounteers

Radiofrequency ablation is a commonly utilized tool in arthroscopic orthopaedic surgery primarily in joints such as shoulders and knees. It allows accurate debridement of soft tissues and control of bleeding. Use of radiofrequency ablation wands produces heat either directly or as a by-product. Studies have shown that if these temperatures exceed a certain threshold, (commonly known to be 45 degrees Celcius), the risk of injury to surrounding tissues within the joint is increases. We will be comparing two types of radiofrequency ablation systems that are very widely used today in arthroscopic surgery. One system, such as the Striker SERFAS Energy probe, uses radiofrequency energy to generate heat at the tip of the instrument. This heat is used to ablate or remove unwanted or damaged tissues and may also be used to coagulate vessels to control bleeding. The other system, such as that used in the Arthrocare RF wands, uses 'coblation' technology. This technology differs in that it uses radiofrequency energy to produce a controlled non-heat driven process where it excites electrodes within the surrounding saline solution to create a charged plasma gas that breaks up molecular bonds within tissue. Heat in this system, is produced as a by-product, and as claimed by its manufacturers, at much lower temperatures. In this study we will be comparing the temperatures established in arthroscopic surgery to determine the risk of injury to surrounding tissues using both these two systems. We will be recruiting 80 patients undergoing arthroscopic knee or shoulder surgery for a variety of conditions. The patients will be randomised to the ablation system and temperatures will be continuously monitored and recorded using an independent digital temperature probe. The probe will be placed in the same location within the joint in all patients through a small key-hole incision. The duration of surgery will also be recorded. Many variable can affect the fluid temperatures and these incluced, baseline infused fluid temperature, flow rate, and number of ports. We will not be regulating these variables in order to create a more natural clinical scenario which will in turn produce results that are more relevant to the common orthopaedic surgeon. Results will be analysed to determine the average and maximum temperatures reached in both systems, and in different types of surgeries (e.g. rotator cuff repair, sub-acromial decompression and acromioplasty, and stabilisation in shoulders, and ACL reconstruction in knees). Statistical analyses will be used to determine if there are any statistically significant differences in results using the two types of ablation systems and whether in fact using the Arthrocare charged plasma 'coblation' process will produce lower and potentially safer temperatures.

The primary objective of this randomised, double-blind, placebo-controlled research study is to determine the safety of topical allopurinol (20mg of allopurinol in SoloSite Wound Gel, Smith and Nephew for 15 minutes) compared with a placebo treatment (SoloSite Wound Gel, Smith and Nephew) for study participants with venous leg ulcers, with a good outcome measured by the lack of adverse effects at the completion of the study (i.e., one week after administration of topical allopurinol).

The aim of this study is to develop a new clinical tool to assist in the design of foot orthoses. This tool will be tested on both feet of each study participant by two different investigators and the results obtained will be compared. We will also be comparing the use of this tool to an established clinical test, the manual supination resistance test. At the end of the study, information on participant satisfaction will be collected.

This study is observing the natural course of hot flash symptoms in men receiving androgen deprivation therapy (ADT) in the form of luteinizing hormone releasing hormone (LHRH) analogues for histologically confirmed hormone-naive prostate cancer. Who is it for? You may be eligible to join this study if you are a male with histologically confirmed and hormone-naive prostate cancer and have commenced on ADT in the form of LHRH analogues for the first time. Trial details In this study, you will be observed for a total period of 3 years. You will be required to complete a validated questionnaire called the Hot Flash Score. This will need to be completed at 1, 2, 3, 6, 9 and 12 months following commencement of ADT. Thereafter, you will be required to complete the Hot Flash Score questionnaire every 6 months until the completion of the study at 3 years. All other treatment and investigations will be carried out according to standard care – that is, no additional pathology tests will be undertaken compared to men who would otherwise not be enrolled in this study.

This is a single-centre, controlled, study using induced blood stage malaria (IBSM) challange inoculum to characterize the effectiveness of Piperaquine against early blood stage Plasmodium falciparum infection. The study will be conducted in up to 3 cohorts (n= 8 in each) using different oral doses of Piperaquine.

The insertion of an arterial catheter is a common intervention in the intensive care unit, allowing continuous haemodynamic monitoring as well as easy access for blood samples and blood gas analysis. Arterial catheterisation is recognised as being a safe procedure, with major complications such as arterial occlusion occurring in less than 1% of cases. Partial or complete dislodgement of arterial catheters, with the attendant risks of re-insertion such as infection and trauma remains an ongoing problem in the intensive care unit. Much effort has been made to improve the standard of securement, with studies focussing on alternative methods of fixation. The study will compare the rate of failure of arterial catheters secured with cyanoacrylate tissue adhesive (tissue glue) with those secured with traditional bordered polyurethane dressings. Dislodgement and subsequent failure of arterial lines is a relatively common problem in the intensive care unit, with associated costs for replacement in terms of staff time, equipment and consumables used and patient comfort. Arterial catheters will be randomised to receive either fixation with cyanoacrylate adhesive or traditional dressings. The primary outcome is the rate of failure of arterial catheters. The secondary outcome is skin reactions or injuries secondary to the fixation method used. The study population will be adult patients admitted to the SCGH ICU. The number of patients for this study will be calculated from the previous audit on arterial catheter failure rates. Inclusion criteria will be arterial catheters inserted in the radial artery. Exclusion criteria will be arterial catheters inserted into an artery other than the radial. Failure is defined as the inability to obtain an arterial waveform and subsequent pressure reading via the catheter, the inability to aspirate blood from the catheter or overt physical dislodgement of the catheter from the artery.

Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, is an approved treatment option for patients with depression in the Canada and several EU nations, with significant evidence demonstrating greater clinical outcomes following longer treatment courses. For patients with fibromyalgia, studies suggest rTMS may also offer a novel treatment approach for pain relief. However these effects are short-lasting thereby limiting its clinical application. Yet no studies to date have explored the effects of a treatment course of similar duration to that used in depression. In addition, there is a dearth of literature exploring target sites other than the motor cortex, such as the dorsolateral prefrontal cortex (DLPFC); a brain region directly implicated in the control of pain perception. In the proposed world-first study, we will carry-out a randomised double-blind placebo-controlled trial to assess the use of an rTMS treatment course applied to the DLPFC in patients who suffer from fibromyalgia. To do so, we will recruit a total of 40 patients with a diagnosis of fibromyalgia who will undergo a blind 4-week acute rTMS daily treatment course. We expect our proposed treatment course of rTMS to the DLPFC in patients with fibromyalgia will provide a model for an interventional treatment course that may be extended to other pain syndromes. Thereby reducing dependence on pharmaceutical treatments in patients who suffer from chronic pain and increasing quality of life for the millions of chronic pain sufferer's worldwide.

This study will develop and evaluate an online communication skills training program and compare it in terms of efficacy to an online + workshop training program for oncology health professionals working with cultural and linguistically diverse patients. Who is it for? You may be eligible to join this study if you are a health professional aged 18 years or more, who has worked for at least two consecutive years in an oncology setting in the fields of medical oncology, radiation oncology or as an oncology nurse. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in both groups will undertake an online communication skills training intervention. This involves undertaking a self-paced, interactive online module (approximately 2 hours in duration), to be completed within two weeks of completing the baseline questionnaire. Participants in group 2 will also attend a 1 1/2 hour workshop within 12 weeks of completion of the online intervention that will develop communication skills through role-played scenarios. Participants will be assessed on completion of the intervention to evaluate their competence in communicating with cultural and linguistically diverse patients, and satisfaction with the program.

Sciatica or sciatic neuralgia, a common form of lumbosacral radiculopathy, is characterized by low back pain that radiates to the leg below the knee and can be accompanied by sensory loss, motor weakness and reflex abnormalities. Sciatica is considered to be a prognostic indicator of poor outcome among patients with low back pain with a substantial proportion continuing to have persistent pain for two years or longer. The annual prevalence of sciatica is estimated to be between 14% and 2%. While guidelines provide clear and generally consistent recommendations for the prescription of drugs for non-specific low back pain this is not the case for sciatica. Patients with a clinical diagnosis of sciatica are about five times more likely to take drugs than those with low back pain only, with analgesic and adjuvant pain drugs being the mainstay of current treatment. The efficacy of these prescribed medications is varied and conflicting in this population. Gabapentin and Pregabalin represent a newer approach to the treatment of sciatica. Both are analgesics of GABA that modulate the calcium-channel subunits, possibly decreasing the neurotransmitter release associated with the central sensitization that occurs in sciatica. With the recent PBS listing of Pregabalin for neuropathic pain refractory to treatment with other drugs, we hypothesize pregabalin to be superior to gabapentin in reduction of pain for patients suffering sciatica. This head to head clinical trial will examine the effects of both agents in treating pain associated with sciatica compared to placebo in a randomised controlled setting.