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A prospective, feasibility study evaluating the safety and effectiveness of Saluda Medical’s Neurostimulation Technology incorporating neural response measurement and feedback control to treat patients with chronic pain in an extended trial
The primary objective of this study is demonstrating the effectiveness of feedback control on neural stimulation in patients with chronic pain with regard to pain relief and stimulation side effects in an extended trial. A new technique has been developed to measure Evoked Compound Action Potentials (ECAPs) or neural responses to neural stimulation, on the same lead that delivers the stimulation. Three devices have been developed to measure ECAPs and provide feedback control of stimulation current in patients undergoing a trial of SCS for the relief of chronic pain: Multi-Channel System (MCS), Body Worn System (BWS) and an External Trial System (ETS). All the participants may be tested with all these devices. MCS is not a portable system and is used in the operating room or at the clinic. BWS and ETS are similar and used for ambulatory testing, however due to short battery life of the BWS, this device will be used for ambulatory testing at the clinic and ETS is used as a take home device for an extended trial. This research will help advance neurostimulation technology.
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The Effect of Spinal Manipulation upon Local and Remote Deep and Superficial Pain Perception
The aim of the study is to investigate whether manipulation of the lumbar spine effects measures of deep and superficial pain intensity at local and remote locations, for up to 30 minutes post manipulation. We also aim to investigate whether, if differences exist, these changes follow a segmental or non-segmental pattern, and whether the side to which spinal manipulation (SM) is applied creates asymmetrical changes in pain intensity.
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Safety, Pharmacokinetics and Pharmacodynamics of ALD403
Purpose: To determine the safety of multiple subcutaneous (SC) injections ALD403 compared to placebo in healthy female and male subjects. To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 compared to placebo in healthy female and male subjects.
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Feasibility of creating an enriched environment and subsequent impact on activity levels for stroke patients in an Acute Stroke Unit.
Stroke survivors who are in an Acute Stroke Unit have been found to spend the majority of their day inactive and alone. Growing evidence recommends that stroke survivors should retrain activities of daily living and ambulatory function as early and frequently as possible. One approach found to increase activity levels during inpatient rehabilitation is the use of an enriched environment whereby physical, cognitive and social activity is enhanced by creating a stimulating environment. The effect of an enriched environment in an Acute Stroke Unit has yet not been explored. This prospective non-randomized quasi-experimental block design intervention study is focusing on enhancing exposure to an enriched environment to increase activity in an Acute Stroke Unit. We will re-organize the Acute Stroke Unit and staffing to create an enriched environment that safely stimulates patients to be more active on a physical, cognitive and social level without increasing staffing levels. The study will determine if an enriched environment can increase activity levels in people with a stroke in an Acute Stroke Unit within existing staffing levels. We hypothesize that activity levels will increase and that there will be a corresponding trend towards fewer secondary complications and improved functional outcomes for stroke survivors.
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Development of a group e-Parenting Intervention Targeting Behavioural Problems for Children with Leukaemia – A pilot study
The current study aims to assess the feasibility of the Triple P Positive Parenting Program for parents who have a child diagnosed with cancer. Who is it for? You may be eligible to join this study if you are an English-speaking parent of a child aged 2-8 years who has been diagnosed with acute lymphoblastic leukaemia (ALL), and is on the maintenance phase of treatment. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo the Triple P Positive Parenting Program straight away. Participants in the other group will be offered the same program approximately 5 months later. Triple P is an evidence-based program developed specifically to provide parents with practical strategies for dealing with problem behaviour in their children. This intervention will be delivered in an online group format, hence making it accessible to all families regardless of their personal or geographic circumstances. Both intervention and control group parents will complete online surveys measuring parenting strategies, child sleep, child diet, child behaviour and other feasibility questionnaires at three timepoints (2 weeks prior to the first intervention, and again at 2 and 12 weeks post intervention completion). The results from this pilot intervention will be used to inform the development of a cancer-specific Triple P Intervention (CancerCare Triple P) for implementation across multiple paediatric oncology sites nationally.
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Does Evening Primrose Oil Improve Pruritis (Itching) in a Dialysis Population?
Pruritis is a common symptom in patients on dialysis and has significant impact on their quality of life. The pathophysiology is not well understood and treatments are not very effective. Evening Primrose Oil has been used successfully in eczema and small studies suggest it may be of benefit in uraemic pruritis.This study is designed to investigate whether in fact Evening Primrose oil does has a beneficial effect on pruritis.
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Positron Emission Tomography (PET) scan in predicting response and survival in patients undergoing chemoradiation followed by surgery for oesophageal cancer
This phase II study aims to investigate whether PET scan performed after the completion of chemotherapy and radiation can predict response of oesophageal cancer. Who is it for ? You may be eligible to join this study if you are aged 18 years or more, have been diagnosed with a localised oesophageal cancer, and are suitable for chemotherapy combined with radiotherapy prior to surgery. Study details: Participants will undergo a single additional PET scan 4 weeks after the completion of chemo-radiotherapy. Approximately 2 weeks following this they will undergo surgery. Specimens obtained from surgery will be used to evaluate the predictive value of the PET scan. Participants will be scheduled to clinic visits for follow-up at 5 weeks after chemo-radiotherapy, 3 monthly for the first 12 months, and then 6 monthly thereafter until a minimum of 2 years. At each visit, apart from routine history and physical examination, participants will be asked to complete a series of short questionnaires which evaluate the health-related quality of life. This is a prospective, single arm, multi-centre study and a total of 200 participants will be recruited.
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Effects of a high calcium pre-event meal on biomarkers of calcium homeostasis in female cyclists
Background: An issue of high importance to the AIS is the prevention/treatment of low bone density in athletes: low bone mineral density (BMD) is common in both male and female cyclists. This may be because of a lack of weight-bearing activity, menstrual disturbances, and low energy availability due to weight loss practices or the high energy expenditure. An additional risk factor of interest is the acute effect of sweat calcium loss. These sweat calcium losses during prolonged exercise may cause a significant decline in blood calcium concentrations during training. The body protects blood calcium levels by stimulating the bones to release calcium into the blood to restore levels, and increasing bone re-absorption. Purpose: to determine whether a high calcium pre-event meal can reduce levels of hormones that are responsible for increasing bone resorption. Hypothesis: based on previous findings involving calcium-fortified water, it is hypothesised that a calcium-rich dairy based meal will reduce the exercise induced rise in biomarkers of bone resorption observed during cycling.
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The effect of early mobility in patients after Total Knee Replacement on hospital length of stay,pain and function: A randomised control trial
Trial aimed at determining whether mobilising patients after Total Knee Replacement within the first 4-6hrs after surgery compared to mobilising within the 24 hrs after surgery changes the outcome for these patients
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A web-based randomised controlled trial exploring the impact of telephone-based practitioner support in an online parenting program.
Preliminary trials have demonstrated Triple P Online to be an effective self-directed behavioural family intervention for reducing child social, emotional and behavioural problems, increasing parenting confidence and reducing ineffective and coercive parenting practices. However additional research is required to both replicate these results and further investigate factors that might impact program outcomes. The primary aim of this randomised controlled trial is to explore the value of brief, regular practitioner support when used in conjunction with Triple P Online. It is anticipated that parents participating in Triple P Online will demonstrate greater reductions in child disruptive behaviour and coercive parenting strategies than parents in the control group. We also anticipate that parents receiving practitioner support combined with the online program will experience greater improvements than parents completing Triple P Online as a self-directed intervention only.