ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31615 results sorted by trial registration date.
  • Bare Metal BifuRcAtion SteNt Clinical Trial in Humans (IP088) With Coronary Stenosis At or Near a Vessel Bifurcation - Safety at 30-Days

    A prospective multi-center, non-randomized, single arm trial enrolling up to 60 patients with symptomatic ischemic heart disease attributable to a bifurcation lesion that is amenable to percutaneous treatment with stenting. A bifurcation lesion must have =/> 50% stenosis in the main branch. Trial patients may have multiple vessel disease but only a single bifurcation lesion per patient mmay be treated during the trial procedure, with no other lesions of any type treated at this time-point. Clinical follow-up assessment will be performed at 30-days post procedure. Patient contact for follow-up assesment will be performed at 6 months, 9 months and 12 months post-procedure

  • The effectiveness of spinal manipulative therapy (SMT) versus Graston therapy (GT) in the treatment of non-specific thoracic pain: A randomised controlled trial

    At present only one randomized controlled trial has been performed assessing the effectiveness of spinal manipulative therapy on thoracic spinal pain (Schiller 1999). Several limitations were observed resulting in the Schiller concluding that further studies are required. Graston therapy is a massage system revolving around several hand-held stainless steel instruments (Graston Technique 2006). The founders claim that the instruments have the ability to detect fascial adhesions and restrictions, aiding in achieving improved outcomes for conditions such as thoracic pain (Graston Technique 2006). No high quality trials have been performed to test the efficacy and effectiveness of this method. Given the popularity of spinal manipulation and massage for back pain and the lack of data there is a need for further high quality studies The objective of this investigation is to determine the effectiveness of SMT and GT compared to a pseudo-sham in the treatment of non specific thoracic spine pain. Specifically, the null hypotheses are: 1. Perception of pain as measured by a 100mm visual analogue scale (VAS) will not differ between groups after 3 weeks of either SMT, GT or detuned short wave diathermy and detuned ultrasound 2. Function as measured by the Oswestry Back Pain Disability Index will not differ between groups under these study conditions

  • Ultrasound Guided Three-in-One Nerve Block for the Relief of Acute Pain from Fractured Neck of Femur. A Double-Blind, Randomised, Controlled Trial.

    This study is of pain relief for people with a broken hip (fractured neck of femur) in the period between arriving at the Emergency Department and having an operation. Standard treatment of pain is by injections of morphine as required. This study will look at injecting long acting local anaesthetic to the nerves which supply the hip. An ultrasound machine will be used to accurately place the injection. It is hoped that this will give better pain relief than morphine alone with less side effects of nausea and drowsiness. The local anaesthetic is expected to last about 18 hours. This will cover the period from the Emergency Department to Operating Theatre for many patients. Doctors, Nurses and Patients will not know whether local anaesthetic or a saline placebo has been injected. All patients will be given as much morphine as is necessary to control their pain.

  • Comparison of McCoy and Airtraq Laryngoscopes in Patients with Cervical Spine Immobilisation

    Failure to immobilise the neck during tracheal intubation in patients with cervical spine injuries (CSI) can result in a devastating neurologic outcome. One method to immobilise the neck during laryngoscopy and tracheal intubation is manual in-line neck stabilisation (MILNS). With MILNS, however, it is often more difficult to visualise the larynx using conventional laryngoscopy. Consequently, the application of MILNS may result in failure to secure the airway, which may result in substantial morbidity or even mortality. These issues highlight the need to develop alternative approaches to securing the airway in patients with CSI. The purpose of the proposed study is to compare the performance of the Airtraq and McCoy laryngoscopes for tracheal intubation in patients with cervical spine immobilisation using MILNS. The McCoy laryngoscope, introduced into clinical practice in 1993, is a modification of the standard Macintosh blade. It is a familiar anaesthetic tool with an established place in the airway management of patients with immobilised cervical spines. The Airtraq, in contrast, is a novel intubation device. It is a single-use optical laryngoscope with a number of design features that suggest its utility in the setting of cervical spine immobilisation. A limited amount of research to date has generally supported this proposition. We hypothesise that, in comparison with the McCoy, the Airtraq laryngoscope will be associated with faster intubations of reduced complexity. We intend to test our hypothesis by conducting a randomised, single-blind, controlled clinical trial. All patients will receive a standardised general anaesthetic with routine non-invasive monitoring. The neck will be immobilised using MILNS applied by an experienced assistant. Participants will be randomly assigned to tracheal intubation with either the Airtraq or the McCoy laryngoscope. All intubations will be performed by one of two consultant anaesthetists experienced in the use of both laryngoscopes. The primary outcome measures will be intubation time and the Intubation Difficulty Scale score. Any complications or difficulties will be recorded.

  • Podiatry treatment to improve balance and prevent falls in older people

    The aims of this project are to determine the effectiveness of a multi-factorial podiatry intervention to prevent falls, enhance balance and mobility, and reduce disabling foot pain in older people

  • Randomised controlled trial of multimedia patient education approaches to preventing in-hospital falls – Pre-test survey of education materials.

  • ANTS Trial (Australian Neoadjuvant Therapy Study for Non-small Cell Lung Cancer)

    The primary objective of the study is to estimate the benefit of adding cetuximab to standard chemotherapy, administered prior to surgery. Cetuximab inhibits the Epidermal Growth Factor receptor. Additional objectives are to examine the relationships between various measures of tumour shrinkage and various molecular analyses of normal and cancer tissues. This may provide information on how cetuximab works, and which patients benefit most from the drug, as well as further information on the effects of chemotherapy.

  • A phase II/III study to evaluate the efficacy and safety of MD 920 (Gibberellic Acid and Salt 1:1) in patients with hard to heal chronic venous ulceration

  • A randomised, double blinded, placebo controlled trial of the effect of self administered methoxyflurane using the Penthrox® Inhaler on tolerance of the Computed Tomography (CT) Enteroclysis procedure

  • Dialysate calcium study in alternate night nocturnal haemodialysis

    Elevated calcium phosphate product (Ca x P) is an independent risk factor for vascular calcification and cardiovascular death in the end-stage renal disease (ESRD) population (Block et al, 1998). Conventional haemodialysis (4hrs x 3) may not successfully correct the profound disturbances in calcium and phosphate metabolism of ESRD, characterised by hyperphosphatemia and abnormal serum calcium levels. In general a low calcium dialysate (1.3 mmol/L) is used for patients on conventional haemodialysis in North West Dialysis Service (NWDS), at Monash Medical Centre (MMC) and Geelong Hospital and throughout Australia. The calcium and phosphate balance achieved with Quotidian Nocturnal Haemodialysis (8 hours x 6 days) differs significantly from conventional haemodialysis and is associated with marked improvements in the reduction of elevated serum phosphate levels. An observational study by Lindsay et al demonstrated that patients on quotidian haemodialysis utilising 1.25 mmol/L dialysate calcium exhibited calcium depletion and hypocalcemia thus exacerbating secondary hyperparathyroidism (Lindsay et al, 2003). In the same study they demonstrated that an increase in dialysate calcium concentration was associated with a return of bone alkaline phosphatase levels to baseline and a gradual fall of parathyroid hormone (PTH) levels to target range. In association with the increase in dialysate calcium, the use of activated vitamin D compounds fell. Based on the results of this study, it has been common practice to dialyse all nocturnal haemodialysis patients, regardless of whether they dialyse for 8 hrs x 6 or 8 hrs x 3.5, on higher calcium baths (>1.6 mmol/L). It is not clear however, what should be the optimal calcium bath for patients on 8 x 3.5nights/week, particularly as serum phosphate levels are not as tightly controlled with quotidian haemodialysis, and unlike the 6 nights/week group, many patients still require the use of calcium based phosphate binders. Ideally the optimal calcium bath should be such that the overall Ca x P product is <4mmol2/l2 and the PTH 15-30pmol/l, however the concern is that the use of a higher calcium bath in the alternate night group will lead to relative hypercalcemia and an overall increase in Ca x P. Recent evidence also supports the importance of the pleiotropic effects of Vitamin D in addition to its well-recognised role in bone metabolism. It is conceivable that patients being dialysed with a higher calcium bath may not be able to tolerate the addition of Vitamin D due to the development of hypercalcemia. In order to establish the optimal calcium bath in patients on alternate night haemodialysis, we propose a prospective observational study comparing predefined outcomes using >1.6mmol/L and 1.3mmol/L dialysate calcium.

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