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Randomised control trial of ePACT (Electronic Personal Administration of Cognitive Therapy): a flexible treatment for depression and anxiety in adults living with chronic spinal cord injury
Previous research has shown that many people living with spinal cord injury demonstrate great resiliency and lead happy, productive lives. However, there are also many others who experience emotional difficulties such as depression or anxiety. Of particular concern is that the majority of people experiencing those difficulties do not receive any specific treatment or psychological support. To address this problem, a new flexible psychological treatment has been developed - ePACT. ePACT is delivered electronically and supplemented with personal contact by email and/or phone with a mental health clinician. The recent pilot of ePACT was well received, easily accessible and effective for participants who each found it acceptable and helpful. This current study will expand the distribution of ePACT to provide further evidence supporting the effectiveness of ePACT. This aim of this study is to build on the previous pilot study by investigating the suitability and effectiveness of ePACT on a larger body of people.
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Treatment of irritable bowel syndrome: Using dietary carbohydrate restriction and hypnotherapy as complementary therapies
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Current treatment strategies of IBS are unsatisfactory. Currently there are three common modes of treatment for IBS including: drugs, diet and psychological therapies. Pharmacologic interventions are generally not effective in treating IBS and no drug has been shown to relieve the full spectrum of gastrointestinal symptoms that make up IBS. Two common modes of treatment, however, that have been scientifically proven to relieve the symptoms of IBS include hypnotherapy and the low FODMAP diet. Gut-focused hypnotherapy uses hypnosis to induce a deep state of relaxation allowing the subconscious mind to become highly receptive to suggestions directed towards the control and normalisation of gut function. Recently published scientific research has shown that gut-focused hypnotherapy can have a 70+% success rate in the reduction of abdominal symptoms including abdominal pain, bloating, constipation and diarrhoea. Additionally, gut-focused hypnotherapy has been shown to improve overall well-being and quality of life, reduce anxiety and depression and reduce medication needs. Furthermore, these improvements have been shown to be maintained for 2-5 years. FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) are a group of dietary sugars that can be poorly absorbed in people with IBS. When these sugars are poorly absorbed in the small intestine they continue along the gastrointestinal tract and arrive at the large intestine where they act as a food source to the bacteria that normally live there. The bacteria of the large intestine then ferment these FODMAPs and can cause symptoms of IBS. Recently published scientific research has shown that dietary restriction of these poorly absorbed FODMAP sugars (the low FODMAP diet) can have a 75% success rate in the reduction of abdominal symptoms including abdominal pain, bloating, constipation and diarrhoea. Additionally, the low FODMAP diet has been shown to improve levels of fatigue amongst this population. While both the low FODMAP diet and hypnotherapy significantly reduce symptoms in the majority of IBS patients, the benefit of combining these therapies has not yet been investigated. It is anticipated that this study will shed light on the benefit of applying these therapies both individually and in combination with one another, allowing GPs and gastroenterologists to direct IBS patients to the best available treatment which may be tailored to each individual patient. Aims To assess the effectiveness of using dietary carbohydrate restriction (the low FODMAP diet) and hypnotherapy as complimentary therapies for the effective management of IBS To compare the combined treatment of the low FODMAP diet and hypnotherapy to each of the standalone therapies To assess the long term effectiveness of each of the treatment conditions Hypotheses Hypnotherapy will improve IBS symptom severity and psychological status amongst the IBS population The low FODMAP diet will improve IBS symptom severity and psychological status amongst the IBS population Hypnosis and the low FODMAP diet as complimentary therapies will improve IBS symptom severity and psychological status to a greater extent than if these two therapeutic modalities were administered independently Improvements in IBS symptom severity and psychological status will be maintained at 3 and 6 months following each of the treatment conditions
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STRIDER (NZAus): A randomised placebo-controlled trial of a new therapy (sildenafil) to help growth in severely growth restricted fetuses at very early gestations.
Intrauterine growth restriction (IUGR) describes conditions where fetuses are smaller than expected for their gestational age. This puts the fetus at risk of death, hypoxia and preterm birth. If IUGR occurs early in pregnancy (i.e before 28 weeks gestation) survival rates are only 70% and survival free of major handicap (intact survival) is much lower at 20%. Current management involves intensive fetal surveillance and delivery when there is evidence of serious compromise (to avoid death in utero) but this leads to the consequent risks of prematurity. There is no known treatment for IUGR. This is a double blind randomised placebo controlled trial of Sildenafil, a nitric oxide donor drug, that has the potential to vasodilate uteroplacental vessels improving placental function. It may represent a novel therapy for IUGR. It has been used in pregnancy without adverse events and in a small case-control study it improved daily fetal growth velocity. Women with severe early onset IUGR will be invited to take part in the study at MFM units across NZ and Australia. This study will demonstrate if Sildenafil improves fetal growth, the results will be used in collaboration with other similar studies planned worldwide to demonstrate if Sildenafil improves rates of survival free of major handicap. This trial incorporates the STRIDER NZAus Childhood Outcome Study: a follow up assessment of all surviving children at 2-3 years’ corrected age to determine whether any benefit (or harm) seen in the newborn as a consequence of antenatal sildenafil therapy is sustained, or develops, through childhood.
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Gait support for acute and sub-acute patients who demonstrate foot drop following stroke
The QH Rural Stroke Outreach Service and the Queensland Rehabilitation Physiotherapy Network are investigating the use of the Bioness NESS L300 (L300) to support gait recovery in people following stroke with foot drop. A prospective clinical controlled study involving eight rehabilitation units is planned. Each participating site has nominated to be either an intervention or a control site. Following familiarisation, participants will use the L300 during physiotherapy treatment once medically stable until they are discharged or the L300 is no longer clinically required. Participants will be followed up by phone at 4, 8 and 12 weeks following recruitment to the study.
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An Open-label, Single-dose, 3-Period Crossover Study to Evaluate the 2-way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects
An Open-label, Single-Dose, 3-Period Crossover Study To Evaluate the 2-Way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects MK0431G (combination treatment) is being developed for treatment of patients for whom treatment with both Sitagliptin and Losartan is appropriate. However, this study is in healthy volunteers only.
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Best practice pain management in the emergency department: a cluster-randomised, controlled, clinical intervention trial
It is well known that pain management in emergency departments (EDs) could often be improved. A recent study demonstrated that the provision of 'adequate analgesia' (defined as a reduction in the patient's triage pain score of at least 2 and to a level <4 [0-10 scale]) is significantly associated with a high level of patient satisfaction with their pain management. The study concluded that this definition of 'adequate analgesia' could be used as a clinical target for ED staff to aim for. However, this study was only able to demonstrate an association between the provision of 'adequate analgesia' and patient satisfaction. Despite this, the strength of the association is very strong and the 'adequate analgesia' target is about to be rolled out into ED clinical practice. The proposed study aims to take advantage of this proposed roll out by determining if the use of the 'adequate analgesia' target (the intervention) will result in improved patient satisfaction.
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Early tube feeding in head and neck cancer
This study aims to compare the outcome of early tube feeding compared to commencement of feeding as per current standard practice in patients undergoing gastrostomy prior to treatment for head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with head and neck cancer, and have been referred for a preventive gastrostomy (insertion of feeding tube into the stomach) prior to treatment for your cancer. Trial details Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will commence two supplementary feeds per day at the time of feeding tube insertion (gastrostomy). These feeds will be in addition to the patient's usual dietary intake and will continue throughout cancer treatment. Participants in the other group will receive standard care. This involves water flushes via the gastrostomy throughout cancer treatment and feeds will be commenced by the dietitian as clinically indicated during treatment. Participants will be assessed at baseline and 3 months post completion of treatment in order to determine impact on nutrition outcomes, quality of life and clinical outcomes.
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Implementing guidelines to routinely prevent chronic disease in general practice (PEP study)
The PEP study is a partnership between New South Wales, Flinders, Monash, Bond and Queensland Universities, the Royal Australian College of General Practitioners (RACGP), the National Heart Foundation of Australia (NHFA) and the BUPA Foundation. The study is in response to the need to evaluate the uptake and effectiveness of current guidelines for the prevention of chronic disease in general practice, and to develop innovative and effective implementation strategies for the future. The aims of this partnership are to design, trial and evaluate a framework to improve the implementation of the RACGP, the NHFA and NHMRC guidelines for prevention of chronic disease in general practice.
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HealthY Texts: Improving health outcomes for generation Y: assessing the impact of personalised mobile telephone short messages on improving skin protection and early detection behaviours in young to mid-aged adults living in Queensaland, Australia
The purpose of this study is to assess the impact of personalised mobile telephone short messages (SMS) on improving skin protection and early skin cancer detection behaviours among young to mid-aged adults (18 to 42 years). Who is it for? This study is open to consenting participants aged 18-42 years, understand sufficient English, own a private mobile phone, and who have had no previous melanoma with Fitzpatrick skin types I-III (skin that always, usually or sometimes burns and never or sometimes tans). Trial details Participants in this study will be randomised into one of two groups, where both groups will receive a total of 21 personalised text messages over a period of 12 months relating to either sun safety or skin self examination OR in relation to physical activity. The frequency of these text messages is as follows: One message per week for the first three months of the study, then one message per month for the remaining nine months. There are two primary hypotheses for this trial: 1) Provision of personalised sun protection SMS will reduce the proportion of intervention group participants reporting two or more sunburns during the past twelve months by at least 15% compared to no change in the attention control group (physical activity SMS). 2) Provision of personalised skin cancer early detection SMS will increase the proportion of intervention participants who report a whole-body skin self-examination in the past twelve months by at least 10% compared to no change in the attention control group (physical activity SMS). We will also measure satisfaction with, use of, and recall of the SMS messages. The associated secondary hypothesis is that SMS messages are an acceptable and feasible method of reaching people aged 18-42 years with personalised skin cancer prevention messages.
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Study to find out if the drug “Vessel Dilator” is absorbed from an infusion under the skin and is safe and tolerated and improves heart function in people diagnosed with stable congestive heart failure and a moderate degree of kidney function loss.
The purpose of the study is to find out if the drug "Vessel Dilator" (VSDL) is absorbed from an infusion under the skin and whether it improves heart function and has an effect on kidney function in people diagnosed with stable congestive heart failure and a moderate degree of kidney function loss