ANZCTR search results

iX Biopharma Pty Ltd is developing a new capsule formulation of sildenafil for treating erectile dysfunction. Sildenafil as a drug has been approved by the Therapeutic Goods Administration (TGA) in Australia, but the capsule formulation of sildenfil has not been approved by the TGA Therapeutic Goods Administration in Australia or in any other country. This particular formulation of sildenafil, XCalibur (the study drug), and its use in this study are experimental. The study drug will be compared to the pre-existing tablet formulation Viagra.

The aim of the trial is to establish if the use of an online psycho-education and cognitive-behavioural intervention will decrease the likelihood that a young person will experience being cyber bullied, and also reduce the impact of any bullying experienced. The program is designed to decrease vulnerability to bullying by building coping responses over time. We hypothesise that young people who complete the on-line intervention will experience decreased bullying (particularly cyber bullying), increased self-compassion, and decreased emotional and behavioural symptoms from pre-test to post-test, and these changes will either be maintained or improved over the 1-month follow-up..

The primary purpose of this trial is to evaluate the efficacy of vitamin D supplementation for the prevention of progression in men with prostate cancer who have an immediate risk of progression. Who is it for? Men are eligible to participate in this trial if they are aged 50 to <80 and have been diagnosed with localised prostate cancer with intermediate risk of progression, for which they have chosen to go on active surveillance. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either vitamin D tablets, or to receive inactive sham tablets. Tablets in both groups will be taken orally, once per month, for two years. Participants will be followed up at the end of this period to assess for incidence of disease progression and commencement of active therapy. It is hoped that the findings from this trial will provide information on whether vitamin D supplementation is effective for preventing disease progression in men with prostate cancer.

The initial skin incision performed to expose the knee during total knee arthroplasty (TKA) is centred over the patella for ease of access to the joint. This places the scar directly over the bony points of the knee that bear load when kneeling, leaving the skin on the lateral side (outside) of the scar with reduced sensation and sometimes the skin on the medial side (inside) of the scar with painfully altered sensation (dysaesthesiae / neuromata). Placing the skin incision lateral to the edge of the patella (kneecap) avoids the necessity of kneeling on a scar and has been shown to reduced dysaesthesiae and neuromata in other knee procedures. Primary Aim: To prove that lateral skin incisions improve the ability to kneel in patients following bilateral total knee arthroplasty Secondary Aim: 1.Investigate whether lateral skin incision has improved retention of skin sensation. 2.Investigate the ability to kneel after TKA. 3.Investigate if there is improved deep flexion. 4.Investigate whether there is decreased pain and better satisfaction as per patient reported outcome measures (PROM) Research Design: Prospective, Randomized Controlled Trial. Patient Demographic: Eligible patients aged between 40-90 years of age with bilateral, tri-compartmental osteoarthritis (OA),undergoing simultaneous bilateral TKA. Patients with previous knee arthrotomy (cut to the joint capsule) will be excluded. Patients' limbs will be randomized for surgery into two groups; (1) Midline Incision Group and (2) Lateral Incision Group. Outcomes:measured at, six months, and 12 months post-operatively. - Knee flexion and extension. - Kneeling Grade Assessment- a novel grading system has been developed that Grades the ability to kneel from 1-5 depending on how far down the patient can knee. - Area of skin dysaesthesia (uncomfortable change in skin sensation) will be mapped and analyzed using imaging software. - Neuroma formation. - PROMs (patient reported outcome measures).

The primary aim of this project is to determine the influence of two different prosthesis alignment techniques in total knee arthroplasty (TKA) on the soft tissue balance of the knee by using a novel pressure sensor device. Our hypothesis is, that the kinematic alignment of a total knee prosthesis creates a more balanced knee without the need for soft tissue releases. The secondary aim of the project is to determine what relationship prosthesis alignment technique has on patient satisfaction and on patient reported outcome measures (PROMs). The proposed research design is a multi-site, single blinded, prospective randomized controlled trial involving four consultant orthopaedic surgeons at the Mater Health Services North Queensland Ltd, Cairns Base Hospital and the Cairns Private Hospital. Participants will be randomized to either mechanical or kinematic alignment. All participants will undergo the same peri-operative and post-operative protocol process for TKA. All procedures will be planned and performed with the use of patient specific instrumentation (PSI) custom cutting guides based on a pre-operative MRI. These allow the surgeon to make pre-planned bone resections specific to the participant's anatomy. All participants will receive the same total knee prosthesis. The surgical technique will be standardized with respect to the resection of bone, ligament tension assessment and the use of Verasense instrumentation. The Verasense insert will be used intra-operatively to measure pressures across the knee joint during the prosthesis trialing phase, before any soft tissue releases are performed. If the knee is not balanced, then measured steps will be undertaken to achieve balance. All intra-operative surgical data will be recorded. Post-operative patient review will be conducted at two weeks, six weeks, six months, and then yearly. Standard TKA post-operative radiologic assessment will be undertaken to determine the final prosthesis alignment. Outcome measures will include validated clinical pain and function scores such as the WOMAC score, EQ5D, Knee Society Score, the Oxford Knee Score, and the Forgotten Joint Score. Data collected will be analysed using statistical methods in order to find any statistically significant difference in results between the two alignment strategies. Once collected, data will be de-identified (non-identifiable) and sent to an external statistician to perform statistical analysis. All participants will receive PSI Zimmer Nexgen CR Flex TKA prosthesis.

Behaviours of concern (BoC) following acquired brain injury (ABI)– including aggression, agitation and sexual inappropriateness – present significant challenges for the person with ABI, their families, service providers and wider society. These behaviours often result in social isolation and dislocation from accommodation, and represent a significant source of stress to caregivers over many years following injury. Over the past 30 years, there has been a gradual shift towards a focus on modifying the antecedents as opposed to the consequences of behaviour in individuals with ABI. This shift has been led by Mark Ylvisaker and Tim Feeney, through their development of a Positive Behaviour Support (PBS) intervention for people with brain injury and BoC (Feeney & Ylvisaker, 1995, 2006; Ylvisaker, et al., 1998; Ylvisaker, et al., 2003; Feeney 2010). Although the principles underlying the PBS framework reflect current standard best practise, there has been no previous controlled evaluation of a PBS intervention in adults with BoC after ABI. This study will be the first controlled trial of a PBS intervention for BoC in adults with ABI. The creation of this evidence will underpin more efficient and effective interventions and better coordinated care for individuals with ABI and BoC. This project aims to develop, implement and evaluate the efficacy of a Positive Behaviour Support (PBS) model of intervention for individuals exhibiting BoC following ABI which reduces or minimises BoC. It is hypothesised that: *participants receiving the 12-month PBS intervention will show a greater reduction in frequency and severity of BoC on the Overt Behaviour Scale (OBS) (Primary outcome) than a treatment as usual waitlist control group monitored over the same period *the reduction in BoC on the OBS will be maintained at 12-month follow-up. * relative to treatment as usual waitlist controls, participants receiving the 12-month PBS intervention will show a greater increase in community participation, and in quality of life, a greater reduction in attendant care support costs, a greater reduction in score on the Care and Needs Scale, in medication use, in alcohol and drug use, in anxiety and depression symptoms and improvement in family functioning. *The improvements on secondary outcomes will be maintained at 12-month post-intervention follow-up.

The study comprises a cross sectional, case-control study comparing the long term health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids, ammonia and phenol concentrations, serum TMAO, SCFA and BCAA concentrations. Pre-study power calculations have been conservatively based on between group differences in faecal butyrate, with medium effect size (d=0.5) and 80% power. Fifty one self-reported long term followers of the Paleolithic diet (greater than 1 year) will be recruited and age and sex matched with 51 controls (total n=102). Once inclusion criteria are met and consent provided, participants will complete a diet history interview, 3-day weighed food record and provide a 48 hour stool and 24 hour urine collection and blood sample for analysis. Faecal biochemistry (SCFA, bile acids, ammonia, phenol, total moisture) will be determined using gas chromatography (GC) and high performance liquid chromatography (HPLC) methods. Serum samples will be analysed for SCFA, TMAO and BCAA. Food group, and dietary fibre intake will be analysed using SPSS v22.0 (IBM Corporation, 2013) with between groups and within groups analysis being performed. Data obtained from experiment three will be analysed using SPSS v22.0 (IBM Corporation, 2013) and PRIMER-7 (Primer-E, 2015). Outcome variables will be compared to macronutrient intake as continuous variables using general linear modelling. Analysis of data in this manner will provide estimations of risk for changes in outcome variables for changing carbohydrate, fat and protein intake. The study will provide significant information to public health educators in relation to Paleolithic and AGHE dietary patterns. The study will provide a significant contribution to the understanding of how total long term dietary patterns, inclusive and exclusive of grains and legumes contribute to the risks of future development of non-infectious bowel disease, diabetes and cardiovascular disease.

While experts in the field are increasingly recommending Lamotrigine for bipolar II, there has been very little research comparing pharmacological treatment options for bipolar II disorder specifically. Therefore, the objective of the current study is to examine the comparative effectiveness of Lamotrigine and Lithium – both as monotherapies – in a sample of newly diagnosed bipolar II patients, employing a single blind RCT design. We hypothesise that patients will report improvements in mood when trialling Lamotrigine or Lithium medication, and specifically that the Lamotrigine group will report greater improvement and maintenance benefits over the 28-week trial period when compared to the Lithium group. The Lamotrigine group is also expected to report fewer side-effects then the Lithium group.

TEG6S (Haemonetics Corp, USA) is a novel haemostasis analyser that measures viscoelasticity properties of blood using resonance technology. We assessed agreement of the TEG6S analyser between devices, operators, and across multiple time points. We collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). Measurements were performed by one operator on two TEG6S devices (“Interdevice” agreement). Then, 5 different operators performed sample analysis from 5 healthy volunteers, using 5 TEG6S devices (“Interoperator” agreement). Finally, a single operator performed 15 measurements on 4 TEG6S devices, with samples from 5 healthy volunteers, 5 surgical, and 5 ICU patients. Agreement across pre-set time points (0, 15, 60, 120 and 180 minutes) (“Timepoint” agreement) was examined. “Interdevice” agreement was estimated using Lin’s condordance coefficient and further validated using intraclass correlation coefficients and reduced major axis regression. “Interoperator” and “Timepoint” agreement was assessed using the Intraclass correlation coefficient estimated by a random effect regression model.

The primary purpose of this trial is to assess the safety and efficacy of stereotactic ablative body radiotherapy (SABR) for liver cancer which has re-occurred or not responded to radiology treatment (TACE). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with hepatocellular carcinoma (liver cancer), which has been pre-treated with TACE with incomplete response or re-occurrence, and is deemed suitable for SABR therapy by your treating clinicians. Study details All participants enrolled in this trial will receive SABR therapy. The treating team of clinicians may determine that it would be useful to insert fiducial markers in some participants, which are small gold markers, inserted around the tumour to act as a reference point across different images. Within 5 days of fiducial marker insertion (where applicable), all participants will undergo a CT scan simulating the body immobilisation procedure. This will take approximately 45 minutes to one hour. A full body immobilisation system is utilised to create an impression of the body. The CT scan is more in depth than a regular CT and takes multiple images. Small tattoos are drawn onto the patient to act as a guide to allow the lasers to line up during treatment. In order to help the patient stay still and breathe regularly, they are asked to breathe in time with a metronome (typically 30 bpm). Participants will then undergo three SABR treatment sessions over the next two to three weeks, which involves delivery of radiotherapy to the tumour. The treatment takes approximately one hour and consists of using the full body immobilisation system and the tattoo guides to ensure the patient is in the correct position and alignment for the precise delivery of radiation to the tumour. A quick scan is then done to check the positioning, followed by a more in depth CT scan to verify this. When the treating team are happy with the positioning, the treatment radiation dose will be delivered, followed by a pause mid treatment to verify and confirm the positioning once again. Post treatment all participants will be followed up every few months for up to 24 months following completion of SABR treatment. This will involve blood tests, CT/MRI scans to assess tumour progression, and monitoring of the side effects related to SABR treatment. It is hoped that the findings from this trial will provide information on whether SABR, with or without fiducial maker insertion, is safe and effective for the treatment of liver cancer, where the tumours have not responded or re-occurred following treatment with TACE.