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Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, the purpose of this randomised controlled trial is to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. One hundred and twenty DVA clients with foot pain residing in the northern suburbs of Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a “usual care” control group. The intervention group will continue to receive their usual DVA-subsidised podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort [registered trademark]) fitted by a podiatrist. The control group will also continue to receive DVA-subsidised podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12), the number of falls experienced during the follow-up period, the Timed Up and Go Test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of overall treatment effect.

Major depressive disorder is a severe illness of high prevalence. A significant percentage of patients fail to respond to standard treatments and continue to experience marked disability and high morbidity. Repetitive transcranial magnetic stimulation (rTMS), which is a non-invasive means of stimulating nerve cells in superficial areas of the brain, is a promising therapy for those with treatment-resistant depression. Previous research conducted by our group clearly indicates that rTMS has antidepressant activity and that the response to rTMS is clinically meaningful in some patients. Whilst several forms of rTMS are clearly effective, no one type of rTMS has demonstrated markedly greater responses that other approaches. In recent years interest has developed into whether the dose of rTMS, in particular the number of pulses applied, is related to response to treatment (the percentage of patients that respond to treatment, the ‘response rate’). However, as there is a considerable time cost to higher dose protocols, their usefulness requires systematic evaluation. Therefore, the primary goal of this study is to examine whether response to rTMS is greater or more rapid when treatment is applied at a higher dose. To do this we will compare standard and high dose strategies for both low frequency rTMS applied to the right prefrontal cortex, and high frequency rTMS applied to the left prefrontal cortex. A secondary goal of the study is to explore potential predictors of antidepressant response to rTMS using brain imaging analysis.

This is a phase 2 bilateral (both sides of the face), comparison study to assess two formulations of ELAPR (Tropoelastin) compared to Juvederm (Registered Trademark) Ultra Plus for the treatment of moderate to severe Nasolabial folds. Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to the study. Following a screening period of up to 28 days, patients who meet the entry requirements and none of the exclusion criteria will be randomized to receive treatment with one of two ELAPR (Tropoelastin) formulations. Patients will attend the nominated sites for all procedures and be treated by the study investigator. Patients will receive either ELAPR002b (Tropoelastin) or ELAPR002d (Tropoelastin) for the treatment of one NLF, and Juvederm (Registered Trademark) Ultra Plus for the treatment of the second, opposite Nasolabial fold. Treatments will be provided on Day 1 and repeated on Day 29 (if required) and Day 57 (if required). Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, at the discretion of the treating consultant delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle. The needle will be inserted at an approximate angle of 30 degrees parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR (Tropoelastin) and the control may be implanted parallel or perpendicular to the Nasolabial fold. Exactly the same technique will be used for the treatment of both Nasolabial folds for each patient. When the injection is completed the treated Nasolabial fold may be gently massaged if required to enable the implant material to conform to the contour of the surrounding tissues. Following the treatment of the Nasolabial folds, each patient will then have the same preparations (ELAPR002b or ELAPR002d, and Juvederm (Registered Trademark) Ultra Plus implanted as a 0.1ml bolus into the mid-deep dermis of the skin of the medial aspect of the upper arm (left or right arm) using a 27G needle on Day 1. The arm chosen by the patient will receive two implants, approximately 20mm apart, proximal being the ELAPR (Tropoelastin) (according to randomisation) and distal being Juvederm (Registered Trademark) Ultra Plus. The centre of the implants (on the upper arms) will be marked with a needle point tattoo. The tattoo mark will assist in locating the implant sites. Patients will have safety observations for 60 minutes after each treatment. Photographs of the patient's Nasolabial Folds and the upper arm implants will be taken before and after treatment and at each follow-up visit for record keeping purposes only. The two 2mm skin biopsies will be collect at the same visit at Day 57, Day 85 or Day 169 according to randomization from the upper arm implant sites. The 2mm skin biopsies will encompass the needle point tattoo at the centre of the implant site. The biopsy wounds will be allowed to heal by secondary intention wound healing, under a non-stick or waterproof dressing. All Patients will return on Day 8, 29, (36), 57, (64) 85 and 169 for evaluation. If there is no further treatment at Day 29 to achieve OCR, then the Day 36 visit is omitted. If there is no further treatment at Day 57 to achieve OCR, then the Day 64 visit is omitted. Patients will have both upper arm biopsies scheduled for the same visit on Day 57, Day 85 or Day 169. At each visit, patients will be asked questions related to the status of the Nasolabial fold and upper arm implants, skin site texture, skin reactions and any activities undertaken which may impact on the implants. The physical presence of the Nasolabial fold implants will be assessed by the investigator at each visit. To assess the effects of ELAPR (Tropoelastin) and Juvederm (Registered Trademark) Ultra Plus subjective feedback on the comfort and feel of the implant sites will be collected for the Nasolabial folds using a Visual Analogue Scale based questionnaire. Safety evaluations will consist of monitoring and recording of all spontaneously reported and observed adverse reactions to the study device, general physical examination and clinical laboratory safety testing. Extension Protocol An Extension protocol is being designed and will be submitted for approval prior to the first patient reaching the end of the current study. It will be designed to continue follow-up of those patients with persistent study device implant effects at the end of the current study period.

This is sub-study of another trial that is nearing completion. This trial has been registered on the ANZCTR: ACTRN12611001228976, Title: Impact of an Integrated Point of Care Testing service for patients presenting to the Emergency Department on time to disposition decision: a randomised trial. In this trial appropriate patients presenting to the emergency department were randomised to have blood tests performed either by a point of care device or by the central laboratory. There were two main groups that were enrolled: patients with suspected acute coronary syndrome, and a general group of patients who only needed blood tests from the limited selection available by point of care. Randomisation was stratified according to these two groups. The primary outcome of this trial was time to admission/discharge decision. This sub-study involves only those patients suspected of an acute coronary syndrome, and following them up at 3 months for clinical outcomes. The purpose of this study is to demonstrate that performing troponin testing using a point of care device in the emergency department and operated by emergency staff will produce the same clinical outcomes at 3 months amongst patients suspected of having an acute coronary syndrome.

Depression is very common in people with vision impairment and can lead to heightened levels of disability and functional decline. However only a minority of people with vision impairment gain access to psychological support services. Together with Vision Australia and beyondblue we will examine the impact of different depression management options for people with vision loss.

Diabetes is a chronic disease which has no cure, instead optimal glycaemic control is required to minimize complications. However, only 40% of people with diabetes are achieving target glycaemic control, demonstrating that effective disease management for people with diabetes remains a challenge. For some, particularly in rural areas, not achieving target glycaemic controls is at least in part due to poor access to qualified health care providers. Telemedicine has been shown to be effective in improving access to care and lowering the costs in some disciplines, but its application in chronic diseases such as diabetes is still controversial. This research project is designed to evaluate the accuracy and reliability of clinical decisions made when a diabetic patient is consulted by videoconference. This evaluation will be based on comparing the outcomes of specialist consultations provided through face-to-face encounter with video-consultation. Each patient will be seen by 2 doctors – either two face to face consultations one following the other, or a face to face and video consultation. Since doctors do not always agree on their decisions, this arrangement will enable us to determine whether any difference of opinion is a result of the video-conference method, or just normal variation between doctors. If shown to be as reliable as face-to-face consultation for managing diabetes, there will be valuable evidence to support substituting in-person consultation with video-consultation, which paves the way for at least some specialist consultation for people living in rural areas to avoid the expense and inconvenience of long distance travel. In some cases, it may open the door for specialist advice that is currently not available.

50 females with urodynamically proven stress incontience will be randomised to either Monarc or Miniarc suburethral sling surgery and compared with regard to postoperative pain relief, blood loss, and continence at 6 months

The outcome in patients with Acute Myeloid Leukaemia (AML) who fail to respond to treatment or relapse after treatment is extremely poor. There is no standard treatment for these patients. This study aims to compare various chemtherapy combinations, comprising romidepsin and high dose lenalidomide, azacitidine and lenalidomide and high dose lnealiodmide alone in the treatment of advanced AML. The study plans to treat 120 patients in a number of sites throughout Australia and New Zealand. This stage of the study follows on from an initial study that aims to find the appropriate dose of romidepsin. The initial study can be found at http://www.anzctr.org.au/trial_view.aspx?ID=343451 Trial details In this study you will be allocated to receive either: the drug romidespin delivered intravenously (i.v) on days 1 and 15, and possibly 8, of a 6-week treatment cycle with 50mg oral lenalidomide on a daily basis on days 8-28; the drug azacitidine delivered subcutaneously on days 1-5 and 8-9 of a 6-week treatment cycle with 50mg oral lenalidomide on a daily basis on days 8-28; or 50mg oral lenalidomide on a daily basis on days 1-28. Your response to the treatment will be assessed after 2 cycles, and overall, your treatment should continue for at least 6-12 cycles. Beyond this time, the decision as to whether or not your treatment continues will be at the discretion of the study's Principal Investigator (PI). Who is it for? This study is open to male or female patients aged 18-80 with either a diagnosis of Acute Myeloid Leukaemia (AML) and failing previous therapy, either primary refractory or relapsed after no more than 3 previous lines of chemotherapy OR a diagnosis of Myelodysplasia transformed to AML after previous treatment. The full details of this study's inclusion and exclusion criteria can be found in the relevant sections within this record.

The research project aims to show by offering a choice of three different weight loss diets plus the ability to change diet styles throughout the study participants are more likely to remain in the study and more likely to achieve the study goals of a 10% weight loss at 12 months compared with those having usual clinical care.

Knee osteoarthritis (OA) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability. Many patients also experience co-morbidities such as obesity and cardiovascular disease that further add to the OA burden. Interventions that foster appropriate lifestyle behavioural change, particularly in the area of physical activity, are important for chronic diseases such as OA. Physical activity, encompassing both structured exercise and incidental physical activity, is recommended by OA and general health guidelines because of its positive impact on disease outcomes and health status. Both muscle strengthening and aerobic exercise are effective in reducing pain and improving function in the short-term in patients with knee OA. However, benefits are generally not sustained because adherence declines over time. Interventions are therefore needed to facilitate sustainability of physical activity behaviours in patients with knee OA in order to achieve longer-term clinical improvements and to reduce the risk and impact of associated co-morbidities. Evidence-based strategies to improve uptake and adherence to physical activity and/or exercise interventions for people with chronic musculoskeletal conditions include incorporating face-to-face visits with a health professional, support from telephone coaching, refresher or booster sessions, exercise and physical activity plans based on patient preference and individual goals, an educational component, and optional strategies including log-book recording of participation and step counting. Telephone coaching is a relatively inexpensive intervention using widely available technology. It has been shown to improve physical activity behaviours in older adults and in those with other chronic conditions, particularly if combined with face-to-face visits with a health professional. Thus telephone coaching aimed at changing physical activity behaviours may achieve longer-term improved patient outcomes in those with knee OA but there is limited research in this area. This pragmatic trial will investigate the clinical- and cost-effectiveness of a 6-month physical activity intervention on pain and function in people with knee OA. The intervention package incorporates 5 physiotherapy contacts together with 6-12 telephone coaching contacts. The intervention will be compared to a physiotherapy only condition.