ANZCTR search results

This study aims to determine the repeatability of an investigational instrument (Liquid Jet Aesthesiometer) and its application in contact lens related comfort. The instrument is used in optometric research to assess corneal sensitivity (i.e. measuring the smallest amount of stimulus for the anterior eye to detect sensation). To achieve this we wish to take measurements using the instrument over several days. Approximately 30 participants (15 contact lens wearers and 15 non-contact lens weares) will take part in each stage of the study. In Stage 1 of the study, we wish to assess the repeatability of the instrument in measuring corneal sensitivity over the course of 5 days. Once this stage is complete and pending data analysis of Stage 1 we may invite you to Stage 2, if you choose to participate, where we aim to assess the correlation between corneal sensitivity measurements and comfort over the course of 3 days. You do not have to participate in both stages of the study.

It is well established that physical activity is associated with many physical and psychological health benefits. Participating in regular physical activity during childhood is also vital for optimal growth and development and kids who are active show greater resilience and increased social-emotional wellbeing. However, more than 80% of adolescent girls do not meet government physical activity recommendations and there is a striking difference in activity levels between boys and girls at all ages. Current strategies to engage girls in physical activity and sports programs have had minimal impact and innovative approaches that address the underlying socio-cultural barriers that girls face are needed. Targeting fathers to take an active role in increasing their daughters’ physical activity levels may be one such innovation. The DADEE Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, DADEE also targets girls to improve the fitness and physical activity levels, and parenting skills of their fathers. The program has been successfully tested in an efficacy RCT at the University of Newcastle. The aim of this trial is to test the effectiveness of the DADEE Program when delivered by local trained facilitators in community settings (i.e., schools). As in the DADEE pilot study, the two major purposes of this community effectiveness trial are: (i) to help fathers improve their own physical activity levels and learn parenting skills to promote and role model positive behaviours relating to physical activity for their daughters (ii) to improve the physical activity behaviours, fundamental movement skill proficiency and social-emotional well-being of their daughters.

This study aims to collect out-of-pocket costs of treatment and management of cancer in patients in three centres in Sydney, Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of any cancer (early or advanced), are receiving at least one cancer-directed therapy which is expected to continue for at least 3 months, and are under the care of a Medical Oncologist at a centre participating in the study. Study details All participants will complete a questionnaire collecting basic details about their age, income status, sociodemographic details and those of their cancer and it's treatment. They will also complete up to 3 cost diaries which will collect information regarding out-of-pocket costs of their treatment, investigations, appointments, and travel. Participants will grade on a Likert scale how easy to how difficult it was to complete the diaries. Finally, participants will also be required to complete two questionnaires at the end of the three month study period, to evaluate financial distress/toxicity. The information that is collected will help to inform healthcare professionals, patients and government bodies of the costs of cancer treatment and the impact of these costs.

This research will compare commonly used types of orthodontic removable retainers and assess the changes in tooth position that occurs from immediately post treatment to 3 months and 6 months after orthodontic treatment is complete. Patient reported satisfaction from wearing the retainers will be assessed with the use of a questionnaire.

This study is aiming to recruit 50 participants that have HER2 positive metastatic breast cancer with 1-5 synchronous brain metastases, with at least one met requiring treatment. The purpose of the study is to determine; 1. How likely the tumour/s are controlled after treatment with local therapies Neurosurgery (NS) and/or Stereotactic Radiosurgery (SRS). 2. How likely is it that other tumours develop at new sites in the brain when no Whole Brain Radiotherapy (WBRT) is given. Study Details: For patients who have HER2 positive breast cancer which has spread to the brain (metastasised), the main treatment options for these brain metastasis are Whole Brain Radiotherapy (WBRT), Stereotactic Radiosurgery (SRS) and Neurosurgery (NS) Participants will be given either SRS or surgery or a combination of both depending on the particular features of each tumour. All participants will be followed up at regular 3 monthly intervals for 12 months after completing thier trial treatment (i.e. from the day of their last SRS treatment or of neurosurgery, the latter of the two). At each follow-up visit they will have a clinic visit with the study doctor who to assess any symptoms, record current medications and/or surgeries, monitor their brain metastasis, have a blood test and imaging (CT scan, a bone scan and MRI brain).

This study is comparing the analgesia outcome of surgically guided direct vision Transverses Abdominis Plain ( TAP) block versus standard surgical infiltration of Pfannenstiel wound during elective Lower Uterine caesarean Section (LUCS) delivery via the Pfannenstiel incision, under Neuraxial Blockade (NAB) anaesthesia at 2, 6, 12, 24, and 48 hours postoperatively. The Null hypothesis is that there is no difference in analgesic outcome between these two techniques. The study will also seek to compare post operative nausea and vomiting PONV rates, sedation, pruritis and patient satisfaction score between these two groups. It will also look at ease of instillation of the Local anaesthetic in the correct plane and whether this correlates to analgesia outcome.

Developmental disabilities and neuromotor disorders such as childhood apraxia of speech (CAS) can result in delays in speech articulation, language production and reading in children. Traditional CAS therapy involves extended one-­on-­one therapy with a speech language pathologist (SLP), which can be difficult to manage due to time constraints and expenses. Thus, there is a need for practical and cost-­effective technological interventions to complement traditional face-­to-­face therapy sessions. Electronic speech therapy aids are rapidly gaining acceptance as valuable clinical tools. Studies have shown that children with speech disorders have higher levels of engagement with computer-­based interventions than with traditional therapy. Mobile apps for speech therapy have also become increasingly popular as touch-­based devices (e.g., tablets, smartphones) are intuitive and engaging compared to desktop and paper-­based alternatives; and cost-effective for in-­home therapy. Though the existing tools facilitate practice at home, they are standalone apps with no remote and automated speech assessment. The lack of automatic assessment capabilities makes it hard to monitor progress effectively and adapt the therapy regimen on-­the-­fly to meet the specific needs of each child. Our team has developed a system called Apraxia World that includes speech­-driven games for tablets to deliver speech therapy exercises remotely, and speech processing algorithms required to extract disorder-specific variables for use in controlling gameplay and accurately monitoring therapy progress. We will clinically validate the use of remote speech therapy as an effective medium for intervention in CAS with this intervention effectiveness trial conducted through the University of Sydney.

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.