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Efficacy of the 'Support for Life' program on improving quality of life for people with dementia or cognitive decline and their families or carers
Expand descriptionPeople with dementia, their carers and families will be supported to identify services that meet their individual need and provide them greater control and choice. This will help ensure that these services/supports include opportunities for people with dementia full access to ‘life activities’ such as employment and recreation. Support will also focus on providing family members and/or carers the ability to actively participate in society and not be disadvantaged by their caring role. Active participation may mean continuing to work, attend school, university and receiving appropriate support in these environments. Staff providing support to people with dementia and their carers/families will be provided with: adequate resources and autonomy, capped case loads, access to appropriate emotional support, and an assistant and volunteer staff to assist with the identification/creation of services/activities and where appropriate the provision of support.
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SAFE – Effectiveness of Mckenzie based self-management for the secondary prevention of a recurrence of low back pain.
Expand descriptionSAFE will be a pragmatic randomised controlled trial comparing, a McKenzie based self-management method where participants in the intervention group will attend 2 x 30 minute individual sessions with a trained physiotherapist and the control group will receive advice delivered over the phone and an educational booklet on how to manage back pain. 396 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through community and website advertisement and primary care clinicians (GPs, physiotherapists and chiropractors). Participants will be followed up for a minimum of 12 months. The primary outcome will be days from randomisation to first self-reported recurrence of an episode of activity limiting LBP (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). The secondary outcomes will be days from randomisation to first self-reported recurrence of (i) an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours), (ii) an episode of care seeking (with consultation to a health care provider) LBP and impact of back pain measured by the Impact of Back Pain Questionnaire using 9 items of the 29-item PROMIS form.
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Effect of extra intravenous (IV) nutrition compared to standard IV nutrition on growth in moderately preterm babies
Expand descriptionMany babies are born early for a variety of reasons. These premature babies have more problems with growth and later development than other babies born at term. Babies born between 6 and 10 weeks early miss out on the important nutrition from the placenta. In addition, these newborn babies often lose further weight in the first week of life. Despite these recognised problems there is very little research about how best to address these issues. At present, these babies receive a simple sugar and water solution through an IV line whilst building up oral feeds with either breast milk or artificial formula. As a result many babies lose weight but also protein and fat as the simple sugar and water solution is unable to provide these babies with the more complex mixture of dietary supplementation they require. It is the purpose of this study to provide premature babies born between 6 and 10 weeks early with a more complex dietary infusion delivered through an IV line to improve their nutrition and reduce weight loss after premature birth. Ninety babies will be enrolled in the study with each having an equal chance of receiving either the routine sugar and water IV solution or a combined solution of sugar, protein, fat and water also through an IV line. The baby’s growth will be monitored up to three weeks of age. This study will provide important information about how best to improve the nutrition in premature babies, which we hope will also improve their longer term outcomes.
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The Treatment Of BOoking Gestational diabetes Mellitus Study: Evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking.
Expand descriptionIdentifying and treating women early in pregnancy with significant hyperglycaemia at glucose values on oral glucose tolerance testing (OGTT), characterised as Diabetes in Pregnancy (DIP), is important as it improves maternal and fetal outcomes. Similarly, there is good evidence from randomised controlled trials (RCTs) that identifying women with lesser degrees of hyperglycaemia on OGTT and characterised as Gestational Diabetes (GDM) at the end of the second trimester of pregnancy, also improves such outcomes. There is, however, currently no randomised controlled trial (RCT) evidence that using the same criteria to diagnose and treat women for GDM prior to 24-28 weeks gestation, benefits either babies or their mothers, while there is potential for harm through fetal undernutrition, inappropriately medicalising some pregnancies, and increasing overall clinical workload. ToBOGM is a multicentre RCT comparing immediate referral for treatment for those women with ‘booking GDM’ on OGTT vs treating such women as normal and awaiting the results of a repeat OGTT at 24-28 weeks, proceeding to treatment only if GDM is diagnosed at that stage. TOBOGM has been through peer review and is to be funded by the National Health and Medical Research Council (NHMRC).
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A Prospective Observational Study Assessing The Role of IL-6 On The Platelet Protective Effects of Paclitaxel-based Chemotherapy in Patients with Epithelial Ovarian Cancer
Expand descriptionSummary People diagnosed with ovarian cancer will receive chemotherapy either prior to (neoadjuvant chemotherapy) or following surgery (adjuvant chemotherapy). Previous research has confirmed the importance of treating people with ovarian cancer with regimes that contain carboplatin. As with all chemotherapies there are side effects associated with carboplatin treatment which include fatigue, nausea, vomiting and altered kidney function. More importantly, carboplatin treatment can have a significant effect on the bone marrow of people being treated, leading to anaemia and immunosuppression. In particular, carboplatin can decrease the number of cells known as platelets which are responsible for blood clotting. Therefore people whose platelet cell count is low as a result of carboplatin treatment are at risk of bleeding and the treatment doses and timing are affected. Currently, there is no adequate explanation for this observation. There have been reports confirming that paclitaxel can increase the blood concentrations of particular proteins associated with inflammation (cytokines) that are also responsible for stimulating platelet production. One such cytokine is called interleukin-6 (IL-6). This study aims to investigate whether the IL-6 protein is responsible for protecting platelets in people receiving paclitaxel. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above, with histologically confirmed epithelial ovarian cancer considered for neoadjuvant chemotherapy. Study details Participants in this study will receive the standard doses of carboplatin and paclitaxel used for first-line chemotherapy in the ICON Cancer Care, Johns Hopkins and MD Anderson and Gustave Roussy Gynaecological Oncology units. Chemotherapy regimens will be given as per local unit guidelines until the point of completing at least 3-4 cycles of treatment or prior study withdrawal. The primary difference between standard of care and this research is the collection of 10 ml blood for plasma samples for pharmacodynamic assessments at pre-treatment with each cycle of chemotherapy.
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A safety and effectiveness of a gel containing 3% of active AKP-11 for pain and inflammation in arthritis participants.
Expand descriptionArthritis is a disease that affects mainly the joints. Arthritis is a chronic, inflammatory disease characterized by swelling, tenderness and pain. AKP-11, is an experimental topical (applied to the skin) formulation being investigated for its potential as a treatment for arthritis. AKP-11 is anti-inflammatory drug candidate being developed for the treatment of arthritis, including gout, with mode of action targeting many pathological events at the same time.
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A Comparison of Different Patellar Implant Designs in Total Knee Replacement.
Expand descriptionAim: To compare the intra-operative and post-operative outcome measures between three different patellar implant designs in patients undergoing total knee arthroplasty (TKA) surgery with regards to patellar bone coverage and tracking, patient-reported outcomes and post-operative radiological and scintigraphic analysis. Background: Controversy remains regarding whether the patella should be resurfaced in total knee arthroplasty. However, at present the scientific literature supports patellar resurfacing with regards to reduced re-operation risk and improved long term patient satisfaction. Two basic techniques present for resurfacing the patella; either onlay or inset. In the inset design, a round domed implant is reamed in the patella and fixed with a single central projection (peg). On the other hand, the onlay design has either round (symmetrical) or oval (asymmetrical) shaped patellae with three small peripheral pegs fixed on the cut surface of the patella. When using a round patellar implant, either onlay or inset, some surgeons perform a lateral facetectomy to avoid lateral compression syndrome and enhance patellar tracking. However, neither method has proved to be superior. A wide range of complications are associated with patellar resurfacing. These include patellar fracture, osteonecrosis related to devascularisation, patellar polyethylene (PE) wear, aseptic loosening, instability, dislocation, overstuffing and rupture of the extensor mechanism. Many of these can be catastrophic. One should always consider the peculiar blood supply to the patella during TKA and patellar resurfacing as iatrogenic disruption of supplying vessels has been identified as a major contributing factor in post-operative patellofemoral complications. The hypothesis of this study is that onlay oval design provides optimal bone coverage, better tracking, better patient reported outcome scores and carries the lowest risk of osteonecrosis in comparison with the other two designs. Trial Objectives: To prospectively compare intra-operative observed measures, patient-reported outcome measures and radiological results between inset, onlay round and onlay oval designs of patellar implants in patients undergoing total knee arthroplasty surgery. Specifically, we will compare patellar surface bone coverage, pain and functional scores together with patellar tracking and vascular status of the patella postoperatively.
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Use of Patient Controlled Analgesics in the management of pain in Orthognathic Surgery – A randomised controlled trial pilot study
Expand descriptionThe aim of this project is to show whether if there is a difference in the length of hospital stay and effect on health economics for patients who are using ‘patient controlled analgesics’ (PCA) compared to those patients who are on conventional oral or intravenous pain relief administered by nurse. The significance of this project is that, if there is a difference between the two groups, PCA and conventional pain relief group, this can help improve the cost of service to the patient. Reduced length of hospital stay means earlier discharge for the patients to their own environment for recovery and prevents nosocomial infections, this will also free up hospital bed for other patients and reduce the cost of administering PCA. The research question is whether there is a difference in the length of hospital stay for patients who are using PCA compared to conventional analgesics after orthognathic jaw surgery. Our hypothesis is that, those patients who are on PCA will have prolonged hospital stay compared to those who are on conventional oral or intravenous analgesics.
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Effects of energy distribution across three main daily meals on the regulation of blood glucose during prolonged sitting compared to prolonged sitting with frequent active breaks
Expand descriptionEnergy distribution (i.e., timing of calories ingested) and sedentary behaviours are important factors for glucose metabolism. Most Australians currently consume the majority of their energy in the evening, with dinner and an evening snack contributing up to 45% of the total daily energy intake. The pattern of increased energy intake in the evenings has previously been associated with an increased risk of obesity while partitioning calories normally consumed from dinner to earlier in the day (i.e., breakfast) has been associated with better appetite control and lower blood glucose and blood insulin levels-two important risk factors for type 2 diabetes. In addition, the extent to which sedentary behaviours (particularly prolonged periods of uninterrupted sitting) may contribute to the negative effects back-ending current feeding patterns is not well understood. However, earlier consumption of energy (i.e. larger breakfasts) and may be more beneficial to glucose metabolism in the context of prolonged periods of sitting. Similarly, frequent active breaks in the form of simple resistance exercises may also improve glucose metabolism when performed during extended periods of sedentary behaviour. Consequently, the aim of the present study is to examine how manipulations to the distribution of energy throughout the day influences blood glucose and insulin metabolism, and appetite control, during periods of prolonged sitting compared to breaking-up sitting time with intermittent simple resistance exercise in overweight/obese men and women. It is hypothesised that a day of prolonged uninterrupted sitting may potentially accentuate the effects elicited by a high caloric end-of-day feeding pattern compared to prolonged sitting interrupted by simple resistance exercises in individuals with pre-diabetes and Type 2 diabetes.
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Is the use of Niagara Thermo Cycle Pad effective for knee pain?
Expand descriptionThis study aims to assess the efficacy of use of two different Niagara Thermo Cyclo Pad units, used twice daily for 20 minutes for four weeks on knee pain, stiffness and symptoms in knee osteoarthritis patients, using a randomised, placebo–controlled double–blind design over four weeks.