ANZCTR search results

The primary objective of this study is to determine the safety and tolerability of autologous stromal vascular fraction (SVF) and PRP in comparison to standard conservative management of patients with focal chondral lesions of the knee. Secondary objectives are intended to measure differences between standard treatment and SVF based therapies including improvement of pain and mobility, quality of life and MRI to assess disease modifying activity.

Anal fistula is a common condition. The aims of treatment are fistula healing, prevention of recurrence and maintenance of continence. Treatment options and their associated risks vary according to the fistula track. Simple fistulae (intersphincteric or low trans-sphincteric) may be treated successfully with fistulotomy. Complex fistulae pose a therapeutic challenge and carry a higher risk of treatment failure, altered continence and recurrence. (Joy and Williams 2002) (van okelen, Gosselink et al. 2013) To date, no single intervention simultaneously fulfils all three therapeutic aims. The cutting seton has been employed for centuries and involves the use of various materials (including suture, vessel loops etc) to slowly divide through the sphincter and induce fibrosis. The literature reports recurrence rates in the 3 – 5 % range (Vial, Pares et al. 2010) . Reported incontinence rates after cutting seton vary widely from 0 - 63 % (Vial, Pares et al. 2010) (Garcia-Aguilar, Belmonte et al. 1998) (Karri-Pekka, Hamalainen et al. 1997) (Charua-Guindic, Mendez-Moran et al. 2007) (Ritchie, Sackier et al. 2008) , which may be partially attributable to incomplete/inadequate scarring behind the seton when tightened rapidly. The ligation of the intersphincteric track (LIFT) procedure was described in 2007 as a sphincter preserving technique for high fistulae. (Rojanasakul, Pattanaarun et al. 2007) Early reports published fistula cure and continence rates in excess of 90% (ref). Subsequent series have reported success rates ranging from 57% to 82%. (Yassin, Hammond et al. 2013) The procedure involves identification, dissection and then ligation of the fistula track in the intersphincteric space, thereby eliminating the fistula source from its track and avoiding the need for sphincter division. Multiple interventions to manage fistulae have been described including sphincter preserving techniques such as fibrin plugs and tissue glue. (Ellis and Clark 2006) (Garg 2009) With the prospect of altered continence as a complication, heterogeneity of fistula anatomy, and the interplay with physiology, studies are limited in their ability to generalise findings and recommend treatments in the form of guidelines. Aim To prospectively assess the clinical outcomes of patients with complex fistulae treated by cutting seton and compare these to patients treated by LIFT.

Obesity is a growing health concern with the effect of bariatric surgery on weight loss being significant (Buchwald et al., 2004). However, a considerable number of bariatric patients maintain or regress back after a period of time to an unsatisfactory weight (Brolin, 2002). It is proposed that 20-30% of bariatric patients do not successfully achieve appropriate weight loss (Sjostom et al., 2007; Heber et al., 2010). This sparks interest into how the post-surgery care process can be improved, with current post-surgery care focusing on providing dietary requirements in order to promote healing and maintain sufficient nutrients and hydration (Shannon, Gervasoni, & Williams, 2013). Bariatric surgery is effective in altering the volume of food consumed but further help is needed in order to change the types of food and dysfunctional eating habits (Shannon, Gervasoni, & Williams, 2013). The study being proposed will combine a local business product in a clinical trial with Dr Peta Stapleton’s comprehensive research on psychological acupuncture (‘tapping’) for food cravings and weight maintenance. The product is Portion Perfection; a balanced, low Glycemic Index, portion controlled eating plan, based on sound portion control research, over 20 years clinical experience and presented in a simple pictorial format. Three treatment groups are proposed for bariatric patients 1 years post surgery with a Body Mass Index still greater than 30: 1. Usual dietitian care versus 2. Dietitian Portion Perfection Bariatric kit versus 3. Dietitian + Perfect Portion Bariatric kit + Tapping Emotional freedom techniques (EFT), is a form of acupuncture using a tapping process with a cognitive component which has emerged as an effective technique for curbing food cravings (Stapleton, Sheldon, & Porter, 2010) and aiding weight loss (Church & Wilde, 2013). The EFT + kit group will also receive support via a private/secret Facebook group for Q&A related to the EFT trial videos. The primary purpose of the study is to determine whether using the Portion Perfection plates and bowls to eat from every day affects weight loss and psychological symptom improvement for people who have had bariatric surgery over a year ago and are still obese, and whether adding an online EFT (tapping) program further improves these outcomes.

Research combining imaginal exposure and cognitive procedures, with the manual stimulation of acupuncture points (e.g. Emotional Freedom Techniques [EFT]) for food cravings in overweight/obese adults has revealed significant improvements in weight, Body Mass Index, food cravings, subjective power of food, craving restraint and psychological coping for participants from pre- to 12-months after an 8-week treatment, and . These treatments are typically delivered in person, in a group format, so participants must attend in person. This study will investigate the delivery of the same 8-week treatment program for food cravings in overweight/obese adults, but via online delivery. Participants will receive a weekly video email of the treatment program (Dr Stapleton) which will teach the treatment process via pre-recorded video for that week. Weekly handouts and email support form the lead researchers will also be supplied. Web-based technologies offer enormous potential for increasing members of the public’s access to evidence-based health and wellbeing services, as well as offering psychologists increased choice and flexibility in delivering services to populations where previous access has been poor. Therefore the program will be: an email-based education intervention which is self-guided, but with human-support.The broadest and most comprehensive meta-analytic study of the efficacy of internet supported therapeutic interventions has revealed moderate to large effect sizes in targeted cognitions, emotions and/or behaviours (Barak, Hen, Boniel-Nissim, & Shapira, 2008).

The purpose of the study is to evaluate the effectiveness of a community-based education and support program (CarFreeMe) developed in Queensland in improving community participation for people following traumatic injuries,

Mindfulness is the process of bringing deliberate attention to the present moment in a non-judgmental way (Kabat-Zinn, 1994), and has been argued by many to be a potential tool for improving sporting performance (Birrer, Rothlin, & Morgan, 2012; Gardner & Moore, 2012; John, Kumar, & Lal, 2012). A significant proportion of the research on mindfulness in sport has not looked at performance, but instead explored the influence of these approaches on presumed mediators of performance such as flow (Aherne, Moran, & Lonsdale, 2011) or self-confidence (Muangnapoe, 1998). Those that did look at performance tended to use case studies (e.g., Schwanhausser, 2009) or non-randomised designs (e.g., Hasker, 2011). These designs make it difficult to establish the efficacy of the intervention due to the number of confounding variable such at experimenter attention, the placebo effect, or different coaching staff. For the mindfulness component of this study, the primary objective is to explore the effectiveness of brief mindfulness program as a method of improving performance using a more internally valid, randomized and controlled design.

The primary purpose of this trial is to evaluate the efficacy and cost-effectiveness of the ACE smartphone application for reducing distress and unmet needs in cancer patients. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been newly diagnosed with any cancer type including both solid tumors and haematological cancer stages 1-3, attending day oncology centers for cycle 2-5 of adjuvant chemotherapy or fraction 2-5 for radiotherapy treatment for cancer. You must also speak English and have access to a Smartphone or similar tablet device (Android or iOS). Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the ACE smartphone application or to receive standard care with no smartphone application. Those in the ACE group will receive access to the application for four months. The ACE application allows participants to view and amend their existing appointments, provides links to cancer information and improved access to the Cancer Council Information and Support Service helpline. The application will also ask participants to rate their level of distress once per month, and participants with elevated distress levels will be referred to the Cancer Council Helpline for a follow-up support phone call. All participants will complete a number of questionnaires relating to their distress, quality of life and use of healthcare resources at enrollment and 4 and 12 months after enrolment. It is hoped that this study will show that the ACE smartphone application is a cost-effective tool for reducing distress and unmet needs in cancer patients.

The primary aim of this research is to determine how cardiovascular risk factors are managed in patients with atrial fibrillation. Recent research suggests that optimal cardiovascular risk factor management leads to reduced atrial fibrillation burden and better quality of life yet little is known about how well cardiovascular risk factors are currently managed in South Australians with atrial fibrillation. Secondary aims include: - determining factors associated with an optimal cardiovascular risk factor status -determining associations between cardiovascular risk factor status and health care burden - determining associations between patient knowledge of their condition and health care burden The hypothesis is that cardiovascular risk factor management in patients with atrial fibrillation is sub optimal and opportunities to improve outcomes in this population exist.

Quetiapine is a commonly-prescribed drug with a good safety margin that is prescribed in psychotic illnesses, agitation and anxiety. Thyroid function is commonly checked in patients with psychotic disorders and signs of anxiety. We have observed that some patients taking quetiapine have low results on measure of free thyroid hormone level in blood, even though there is no other evidence that their thyroid function is impaired. We suspect this is because the quetiapine is interfering with the laboratory test, but it might actually be a biological effect of the quetiapine and potentially important to quetiapine’s adverse effects on metabolism. We are asking 20 patients in whom their treating psychiatrist has already made the clinical decision to commence quetiapine as part of their management plan, to provide us with a specimen of blood to check thyroid function on 4 occasions (prior to quetiapine commencement, 1 day following commencement of quetiapine, and at weeks 3 and 6 ). We will firstly check to see whether our impression, that free thyroid hormone tests are reading lower in patients on quetiapine by the current test, is correct. The current test is an immunoassay. Then we will use the same blood specimens to measure free thyroid hormone level by another newer, highly specific test (LCMSMS) that is not open to interference in the way immunoassays may be. A comparison of the results will tell us whether the problem is simply immunoassay interference from quetiapine.

The purpose of the SPACS study is to determine the efficacy of smart phone applications as adjuncts in the rehabilitation of orthopaedic patients, in this particular instance - shoulder dislocations. Hypothesis: That smart-phone applications used in conjunction with an industry standardised rehabilitation program will improve patient outcomes represented by comparatively better Oxford stability and instability scores Design: The study will be a simple RCT with two parallel cohorts. One with access to the app. and regular questionnaires and the other with questionnaires only. At the completion of 18 months data collection via the smart-phone apps. the scores between the two cohorts will be compared and analysed Outcomes: the "constant", Orford stability score and Oxford instability scores will used to assess the patients recovery and rehabilitation before being compared to assess the efficacy of the intervention