ANZCTR search results

The COPS trial is a prospective multicentre randomised study to examine the effect of adding low-dose colchicine to standard medical therapy in patients who have had a heart attack. A total of 1009 participants will be recruited from hospitals across Australia over the study period. Participants will be randomised to either (a) standard medical therapy or (b) standard medical therapy plus low-dose oral colchicine. Participants will be followed up for 12 months for predefined major adverse cardiovascular outcomes via telephone interviews. We hypothesise that the addition of colchicine to standard medical therapy will reduce long-term major adverse cardiovascular events in patients who have had a heart attack.

Objective: To investigate the feasibility and usefulness of an online information and skills development intervention for carers of individuals with anorexia nervosa (AN). Method: Thirty-seven carers and seventeen individuals with AN were recruited; carers completed the intervention Overcoming Anorexia Online (OAO), with random allocation to receiving additional clinician guidance (OAO-G) or no guidance (OAO-NoG). Level of expressed emotion, distress, depressive symptoms, experience of caregiving and impact of eating disorder symptoms were assessed in carers and perceptions of changes in their carers’ expressed emotion were assessed in individuals with AN. Participants completed questionnaires at pre-intervention, post-intervention and 3-month follow-up. Results: Significant reductions were found for carer intrusiveness, negative experiences of caregiving and the impact of starvation and guilt. Within group effect sizes suggested mixed findings with respect to whether greater benefits were conferred for carers receiving clinician guidance. Decreases in perceived intrusiveness of the carer by the individual with AN were associated with a large effect size. Discussion: Results demonstrate the feasibility and usefulness of an online intervention for carers. Further examination of the efficacy of the intervention for both carers and individuals with AN is warranted.

Multi-centre study investigating whether specific nutritional interventions improve pressure injury healing compared to standard care. Consenting eligible patients with pressure injuries stage 2 or greater at 5 south East Queensland hospitals will be randomized to receive standard ward based nutrition, intensive dietetic nutrition intervention or prescription of a wound healing formula. Data will be collected at baseline and weekly including a range of relevant demographic, nutritional and pressure ulcer measurements.

Brief summary: Current clinical management of OSA is to use continuous positive airway pressure (CPAP) as a first-line treatment. However, patient tolerance and compliance with CPAP is an ongoing problem in sleep medicine. This study recognizes that alternative treatments better targeted to underlying causal deficits may lead to improved treatment outcomes for patients. Oxygen therapy combined with a sedative (Zopiclone) is one form of combination treatment that could potentially treat a sub-group of OSA patients who have unstable breathing and heightened awakening responses underpinning their OSA. The aim of this study is to investigate if oxygen combined with a commonly used sedative, Zopiclone, could be used to effectively treatment OSA in some patients. Participants will be recruited from the study “CRC Respiratory Phenotyping for Obstructive Sleep Apnea”. The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).

The primary purpose of this study is to determine whether Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scan is more sensitive in detecting small metastatic disease in renal cell cancer than conventional computed tomography (CT) scans. Who is it for? You may be eligible to join this study if you have been diagnosed with renal cell carcinoma in the past 6 weeks. Study details: All participants will undergo a 68Ga-labelled PSMA PET scan in addition to the standard pf care staging CT scans offered. A standard imaging to diagnose renal cell carcinoma is using multi-phase contrast CT scan which participants would have had for the diagnosis. The imaging is then compared to PET scan, which involves receiving a radio-isotope via a drip. This scan is commonly used in prostate cancer staging. You will be required to have an injection, wait 90 minutes, then lie down on a table inside the PET machine for 30 minutes. Scans will be assessed for small metastatic disease and patient records will be assessed to determine if the use of PET scan has changed patient management. It is hoped that the findings of this pilot trial will help to establish whether PSMA PET may be more useful in identifying micrometastases than the CT staging scans alone which are currently being offered. In total, all participants of the trial would have had 1 multiphase CT scan to be eligible for referral, and 1 non-contrast single phase CT scan will be performed with 1 PET scan.

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, relative to young people who do not complete the intervention.

Current standard practice at The Alfred Hospital involves closing the sternum following cardiac surgery with stainless steel wires. Alternative sternal closing techniques also exist, however to date closure of the sternum using stainless steel wires remains the standard technique because of its low cost. The cable tie method of sternal closure however is a widely used sternal closure technique that is used as a standard method by many surgeons in Australia and around the world, as this method potentially provides better stability of the sternum and less postoperative sternal pain. The aim of this research is to compare the outcomes in patients who have their sternum closed either with the Zipfix cable ties or stainless steel wires. The researchers will investigate whether patients who have their sternum closed with Zipfix cable ties experience less pain compared to patients that have their sternum closed with stainless steel wires. They will also determine whether patients who have their sternum closed with the cable ties have reduced sternal mobility in the early postoperative period. We hypothesize that use of the zipfix system for sternal closure after cardiac surgery improves sternal stability and reduces post operative pain, compared to conventional stainless steel wires.

Asthma is the most common chronic childhood disease, affecting one in seven children. Many children have asthma flare-ups, which often results in several sick days requiring increased use of medications, such as ventolin, and may lead to an emergency room visit or even a hospital admission. We have conducted studies in adults, which indicate that certain dietary changes can reduce the risk of an asthma flare-up. However, we do not know whether this is true in children. This study will examine whether the frequency of asthma flare-ups in children can be reduced, by making specific changes to the diet. We hope to gain insight into how diet may be useful for managing children with asthma.

The primary purpose of this study is to determine whether BYL719, an oral selective PI3K alpha specific inhibitor, is a safe and effective drug treatment for adult patients with advanced breast cancer who have progressed after first line anti-cancer therapy. Patients who enrol in this study are required to have their breast cancer genetically characterised so we can understand the mutational profiles of their tumor. Who is it for? You may be eligible to join this study if you are over 18 years old, male or female, with advanced metastatic or locally recurring breast cancer which has progressed after first line therapy. It is a requirement of the study that some of your tumor tissue will evaluated in the laboratory for genetic alterations in their DNA. Regular blood tests will also be required to try to understand if we can detect the breast cancer's abnormal DNA in the blood. Study details All participants enrolled in this study will take the study drug, BYL719, which is an oral selective PI3K alpha specific inhibitor. Dose will commence at 350mg orally daily. This will involve taking tablets daily. Even though the study medication is taken daily, cycles are considered every 4 weeks. Visits to the Oncologist will be required every 4 weeks. Study medication will be continued until disease progression, unacceptable toxicity or requirement for new anti-cancer therapy. Participants will attend regular follow-up visits for up to 2 years in order to evaluate objective response rate, clinical benefit rate, progression free survival, safety and tolerability of treatment. Regular CT and/ or bone scans as well as blood tests will be performed. There will be two cohorts of participants involved in this study – those with advanced/ metastatic TNBC and those with advanced/metastatic ER+/HER2- breast cancers with a genetic mutation in the PI3K pathway. We plan to evaluate the efficacy and safety of BYL719 in these patients and associations with genetic features in order to try to identify biomarkers that can indicate those breast cancers more likely to respond to the study medication.

A pilot Randomized Control Trial providing treatment for children with Childhood Apraxia of Speech using the ReST treatment or Ultrasound Biofeedback. ReST is a newly developed program, based on motor learning principles. It was shown to be effective in treating CAS in a Randomized Controlled Trial and Single Case Design study. Ultrasound Biofeedback treatment trains articulatory patterns using real-time visual displays of the tongue. It has recently been shown to improve productions of consonants and vowels involving the tongue in several Single Case Design studies. This study aims to compare ReST and Ultrasound Biofeedback results when treating CAS in school-age children. Treatment sessions will be delivered by Speech Pathologist or trained Student Speech Pathologist with no home practice required. Participants will have a current diagnosis of dyspraxia or Childhood Apraxia of Speech who will be between the ages of 7;0 and 16;0 years between May 2015 and January 2016. Participants will also have normal or adjusted to normal hearing and vision; no receptive language disorder; speak Australian English and have no other developmental or genetic diagnoses. The research is being conducted by Dr Tricia McCabe and Dr Jonathan Preston. All clinic- based sessions will take place at the Communication Disorders Treatment and Research Clinic on East Street at Lidcombe. All children will receive treatment 2 days per week for 6 weeks for a total of 12 sessions. Each session will be 1 hour in duration. Speech pathologists worldwide repeatedly report feeling unprepared and underskilled in treating children with CAS (Forrest, 2003) The research literature currently contains no high level evidence and only limited high quality experimental single case evidence. Consequently clinicians use ad hoc approaches to intervention with limited success as the research vacuum prevents practice based on evidence from the literature (Pring, Flood, Dodd & Joffe, 2012). The current research will therefore improve service delivery options and reduce uncertainty for SPs in working with children with CAS and their families. We hope to add to our understanding of how motor learning principles should be implemented for children with CAS. We might find that both interventions are equally effective in facilitating improvement in speech production (beyond pretreatment levels) and even this contribution would be useful, as it may indicate that either program can be used. The current study is designed to be a preliminary investigation that could lead to future funding. Pending the results, effect sizes observed here can be used to drive power calculations for future larger-scale studies that may involve variations on the implementation of the procedures for these approaches.