ANZCTR search results

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

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31333 results sorted by trial registration date.
  • Does the perceived intensity of pain experienced with Delayed Onset Muscle Soreness change noticeably over the course of one hour?

    Prior to our research study, we need to perform a pilot study to ensure the stability of the intensity of the DOMS in our subjects over a period of 1 hour, so that any changes recorded in intensity of DOMS during the main study may not be attributed to the factor of time. These data will be used to calculate the sample size in the main study.

  • Enhancing neuroplasticity in the dorsolateral prefrontal cortex using non-invasive brain stimulation: Investigating the effects of repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) on working memory and neuroplasticity in healthy volunteers

    Repetitive TMS protocols are emerging as promising therapeutic tools for the treatment of a number of psychiatric and neurological conditions. The clinical efficacy of these protocols is likely due in part to their ability to promote lasting neuroplastic changes within the brain. rTMS and TBS are two commonly used protocols which have shown some success in transiently altering cortical excitability and treating a number of brain-related disorders. To date, however, the comparative effectiveness of these two techniques remains to be thoroughly investigated. This study will apply rTMS, TBS and sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) in normal healthy participants. Behavioural (n-back task) and neurophysiological (TMS-EEG, EEG oscillations) data will be collected both before and after stimulation, which will provide insight into the effects that each of these stimulation protocols has on both cognitive function and underlying cortical neurophysiology. We anticipate that, compared to sham stimulation, both rTMS and TBS will significantly improve n-back task performance and induce lasting changes in brain activity as measured with combined TMS-EEG and EEG. In addition, we anticipate that these effects will be the strongest following the TBS protocol.

  • Telehealth support for carers of people living with vascular and mixed dementia.

    This trial will offer family carers of people living with mixed or vascular dementia support in their own homes using both telephone and ipad technology to deliver an intervention that combines mental health support for the family carer with information about stroke, dementia and how to manage risk factors. Currently there is little known about how best to provide support for family carers of people living with vascular or mixed dementia over the telephone or using technology such as ipads/tablets. Family carers and people living with vascular or mixed dementia in the community are at risk of social isolation, mood disorders, and carer strain. Risk factors for vascular dementia are high blood pressure, diabetes, smoking and high cholesterol so it is important to avoid and control these risk factors to maintain functioning for as long as possible. Community awareness of dementia and management of behavioural symptoms is low. Face-to-face delivery of interventions can be hard to achieve and costly. With service providers introducing ipads for community clients who choose consumer directed care, there is the potential to utilise the new technology together with telephone support to provide a multi-modal support service in the carer’s own home.

  • Does temporarily altering visual perception of limb size have a modulatory effect on deep pain perception?

    Recent work has demonstrated that non-informative visualisation of the body part (visualisation of the body part without visualisation of the stimulus) decreases our perception of pain when the stimulus is delivered to the skin. Subsequent investigations by the same group verified this finding, as well as demonstrating that the effect is greater when the body part is magnified and less when the area is minified, suggesting a relationship between body image and pain perception. This is important because there is mounting evidence of disrupted body image in people with persistent pain problems, and the degree of disruption seems to be related to the severity of the clinical condition. These results suggest that normalisation of the size of perception of the painful body part might have potential as a treatment strategy. The mechanisms underlying the perception of superficial pain produced by noxious stimulation of the skin are thought to be distinct from those mechanisms that underlie perception of pain mediated by noxious stimulation of deep tissues. Importantly, most clinical pain states are associated with noxious input from deep tissue rather than the skin. Moreover, the one study that has investigated visual distortion in a clinical population noted an effect opposite to those noted above. When patients with complex regional pain syndrome performed a task with their painful upper limb, pain was less when their arm was viewed through minifying goggles and more when magnified. While there are likely to be numerous differences in the mechanisms underpinning clinical and experimental pain, it is possible and theoretically plausible that the contrasting results were a result of the difference between superficial and the more clinically-relevant deep pain. We wish to explore this possibility by investigating the effect non-informative visualisation of the body area has on experimental deep tissue pain. Our primary hypothesis is that visualisation of the body area will have an analgesic effect on experimentally-induced deep tissue pain. We further hypothesise that visually altering the perceived size of the body part will alter the perception of pain when compared with the baseline condition of no alteration in perceived body part size. This research is important as it may provide insight into the role body image plays in influencing deep tissue pain as well as suggesting possible management strategies for pain problems.

  • A prospective evaluation of the utility of ultrasound guided radial artery cannulation versus the traditional blind palpation technique in adult cardiac surgical patients. The ULTRA-ART Study.

    RESEARCH AIMS AND HYPOTHESIS The insertion of radial artery catheters for continuous measurement of blood pressure, as well as easy and regular sampling of blood, is a ubiquitous technique in critical care settings such as the intensive care unit and operating theatre. The radial artery is the preferred site of access due to its anatomic consistency and accessibility, relative ease of cannulation compared with other sites and the low complication rate. In 1990 the number of arterial catheters placed perioperatively was estimated to be 8 million in the United States and 2.5 million in Europe – and this number will only grow as the complexity of patients increases. Despite the ease with which some arterial lines are placed, there are numerous cases in which the operator struggles to obtain appropriate and timely access or causes complications such as bleeding, hematoma formation, psuedoaneurysm, infection, nerve damage, distal limb ischemia, temporary arterial spasm and occlusion, digital embolization / ischemia and patient discomfort. There is currently limited research into arterial line placement at the radial artery using ultrasound in the adult perioperative patient population. This study will evaluate the application of ultrasound guidance to radial artery cannulation in comparison with the traditional palpation technique in the adult cardiothoracic surgical population. The hypothesis of this study is that there will be a difference between the two techniques in time to successful cannulation, number of attempts before successful placement, number of cannulae used, and number of puncture sites per patient. The hypothesis is that this difference will favour ultrasound guidance. In addition, there has never been a cost-analysis performed on the use of ultrasound guidance for radial arterial line placement in comparison to the traditional technique in any population, and this will also be carried out.

  • Does the use of an iodine-containing contrast agent to visualise the PICC tip in preterm babies cause hypothyroidism? A randomised controlled trial

    Preterm babies take time to reach their full quota of oral feeds so often require prolonged intravenous nutrition. Peripheral venous cannulas have a short life span and may result in damage to the skin’s integrity, as well as having a short life span. Long lines or peripherally inserted central catheters(PICC) have a significantly longer life span as the tip is positioned in a large vein.However PICC line insertions are not without complications. The tip of the catheter may reach deep inside the cardiac chambers or fall short of the caval veins and end in entirely unexpected locations. Extravasation of fluid from the catheters in each of these positions has led to serious, and occasionally lethal, complications. These can be avoided if the catheter tip can be precisely localised. The narrow calibre silastic line cannot always be seen on plain radiography but can be visualised with use of a small amount of radio-opaquae contrast. However the contrast available contains Iodine which may cause transient hypothyroidism in newborns. Concerns regarding this have resulted in some units including ours restricting use of contrast when determining line position. The data supporting this decision are very limited and it is unclear as to the role of iodine containing contrast in the development of hypothyroidism. The few studies that have assessed the relationship are either cohort studies, before-and-after study or case series, none being a randomized control trial. The results of these studies are contrasting without any clear answer as to whether perceived benefits of withholding contrast outweigh the risks of developing hypothyroidism. To confuse things further, asymptomatic hypothyroidism is not uncommon in the preterm population. The aim of our study is to compare thyroid function tests in preterm neonates after exposure to IV contrast with controls, to ascertain the impact of a small iodine exposure on the thyroid gland in relation to gestational age. The study will be a randomized control trial for babies less than 30 weeks old requiring insertion of a PICC line. Study infants will be randomised to use of contrast(0.3ml Iopamidol containing iodine 300mg/ml)to assess line position(previous Unit practice) or no contrast. Blood and urine tests will be performed to assess any impact on the thyroid gland of contrast use. Repeat thyroid function tests(TFT) for both case and control will be taken as baseline then 7 and 14days after insertion of the line. Further TFT will be taken if day 7 or 14 results are abnormal.

  • Does the speed of aquatic therapy exercises alter arm volume in women with lymphoedema?

    Project aim: to compare the changes in upper limb volume between a low speed aquatic exercise protocol and a conventional aquatic exercise protocol in women with secondary lymphoedema. We anticipate that slow aquatic exercise (Ai Chi) will have a greater reduction in arm volume than fast aquatic exercise.

  • A Prospective Study of the Effects of Pregabalin versus Placebo on the incidence and intensity of pain after video-assisted thoracoscopic surgery.

    The study proposes to investigate whether a drug with specific effects which damp excessive nerve mediated activity can prevent the long term occurence of pain after chest surgery.

  • A Phase 1 study of Temozolomide, Irinotecan, and O6BG (O6-Benzylguanine) for Children with Recurrent or Resistant Neuroblastoma

    This study aims to evaluate whether treatment with Temozolomide, Irinotecan, and O6BG (O6-Benzylguanine) is tolerable, feasible, and effective for children with recurrent or resistant neuroblastoma (within the confines of a Phase 1 study). Who is it for? You or your child may be eligible to join this study if you/they are aged between 1-16 years and have had a diagnosis of neuroblastoma and it has recurred or is resistant to treatment. Patients need to have exhausted standard curative options of therapy, and must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Study details All participants in this study will undergo chemotherapy treatment with the drugs Temozolomide and Irinotecan, in conjunction with a new investigative agent known as O6BG (O6-Benzylguanine), followed by Peg-GCSF treatment. This is a dose escalation study design, which means that earlier patients will start on lower doses and this will determine the dose that later patients receive. The O6BG (120 mg/m2/day) is given first by intravenous infusion over one hour, followed by oral temozolomide (dependent on dose escalation stage of the study - 40/55/75 or 100 mg/m2/day) and after half an hour, the irinotecan (50 mg/m2/day) is given intravenously for one hour. This treatment is repeated for four more days (i.e. over a total of 5 days). On day 6, the patient is given Peg-GCSF (100 mcg/Kg). Each treatment cycle lasts a minimum of 21 days. Treatment will continue every 21 days until the doctor believes there is no more benefit for the patient. Participants will be regularly monitored to evaluate toxicity (weekly), feasibility of treatment and disease response (every 2 months) until the end of treatment and then every 3 months after treatment until the one year anniversary of the patient starting treatment; at which point patients will be monitored annually therafter up to 5 years.

  • The Australian Grace Risk score Intervention study (AGRIS): a hospital level cluster randomised clinical trial with blinded endpoint evaluation which aims to enhance evidence based decision making and outcome delivery of Australian Acute Coronary Syndrome (ACS) care by evaluating a GRACE Risk score based decision support tool versus standard care

    The Australian Grace Risk Intervention Study (AGRIS) aims to enhance evidence based decision making and outcome delivery of Australian Acute Coronary Syndrome (ACS) patient care. Hospitals will be randomised to either implementation of objective risk stratification using the validated GRACE Risk score based decision support tool or to standard care. It is envisaged that the GRACE Risk tool together with recommendations for evidenced based care will improve the use of evidence based investigations and therapies and therefore enhance secondary prevention in hospital.

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