ANZCTR search results

New international clinical practice guidelines for identifying infants at risk of CP aim to improve earlier detection at 12-24 weeks corrected age (Bosanquet, Copeland, Ware, & Boyd, 2013; Novak et al., 2017; Romeo, Cioni, Palermo, Cilauro, & Romeo, 2013; Romeo, Ricci, Brogna, & Mercuri, 2016; Spittle, Doyle, & Boyd, 2008). Earlier detection of infants at high risk of CP creates an opportunity to provide supportive and targeted interventions earlier during infancy, and to support parental adjustment and the parent-child relationship sooner, from the point of diagnosis. There are currently no parenting interventions designed specifically for parents of infants with cerebral palsy within the infancy timeframe aimed to improve parent adjustment and well-being. The aims of this study are to demonstrate the efficacy of a preventative online early parenting support package: Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants (< 24 months C.A) with CP. We hypothesize that families receiving Early PACT will have improved parent-infant relationships as compared to the wait list care as usual group.

Selective dorsal rhizotomy (SDR) is a well-established neurosurgical intervention intended to permanently reduce spasticity in the lower limbs and improve mobility in selected children with cerebral palsy. The aim of this study is to establish a retrospective and prospective national registry of relevant data pertaining to children undergoing SDR in Australia, and overseas (selection, intervention and outcome). Centres across Australia have agreed on a group of standardised assessments for children undergoing SDR both prior to and after the surgical procedure. The objective of collecting this data is to improve understanding of the short, medium and long term outcomes and any adverse effects of the intervention, and to provide clinicians with information to guide families considering this intervention. Families of children who have undergone or are undergoing SDR (in Australia, and overseas) will be asked to consent to information relevant to SDR being stored in a research-specific online database. Information will be collected from the children's routine clinical assessments. Information will be stored without identifying details to improve privacy. Participation in this trial is voluntary. Data collected in the registry will identify the characteristics of Australian children who have undergone SDR. In addition to details of the surgery including surgical complications; long term adverse events; and outcomes related to the International Classification of Functioning, Disability and Health domains of body structure and function, activity and participation. The primary and secondary outcome measures have been developed for the CP and/or paediatric population and will be collected at baseline, and at one, two, five and ten years post intervention. These include gross motor function and mobility, achievement of goals, pain and quality of life. The need for further interventions after SDR surgery will be collected and include spasticity management and orthopaedic interventions in the ten years following SDR. The prevalence of any long term adverse effects will be collected in the ten years following SDR. The data collected pertaining to adverse events include spine and foot deformity, hip subluxation, sensory impairment and bladder/bowel dysfunction.

Keloid scarring is one of the most difficult clinical problems in wound healing. It can dramatically affect a patient’s quality of life both physically and psychologically. A wide array of treatments has been used to treat keloid scars. Of these, intralesional injection of triamcinolone acetonide is most frequently used. We aim to evaluate the effectiveness of sub dermal injection of triamcinolone acetonide at the time of caesarean section to prevent keloid formation in patients with existing keloid caesarean section scar. This will be a randomized controlled clinical trial. All the patients with a previous caesarean section and presence of existing keloid scar will be included in the study. The patients will be randomized into two study groups. The control group will receive surgical excision of keloid scar then routine wound closure. The treatment group will receive surgical excision of keloid scar then sub-dermal injection of triamcinolone acetone at the time of wound closure after the delivery of the fetus. The patients are followed up for 5 days post operation for complications, then at 6 weeks, 6 months and 1 year post partum.

Within cardiovascular medicine, the process of diagnosis and risk assessment is no longer heavily reliant on clinical intuition alone, but rather increasingly dependent on objectively assessable and electronically recorded information. By harnessing the organ-system and social phenotypes already captured within existing health information systems, this data repository will establish a real-time clinical and health service laboratory that can explore and evaluate the organic biology of the healthcare process model and the people for which it provides care. PHOCQUS aims to develop digital phenotypes of cardiovascular diseases and care, patient comorbidities and social determinants of health, health service characteristics, and measure outcomes through an automated data retrieval and collation by linking currently collected routine clinical health service use and demographic data from various electronic health information systems for all patients under the custodianship of the Cardiology department at Flinders Medical Centre. This study will provide the groundwork for evaluating impacts of health policy and service redesign. Such a repository will also feed back into routinely collected data increasing data integrity, reducing “missingness”, improving interfaces and further standardizing data definitions and workflows. The overall aim of this project is the development of validated data specifications that will enable the implementation of low cost, yet high fidelity, routine clinical quality registries in cardiovascular care.

Eligible patients will randomly assigned (50/50 chance) to receive both the propagermanium and placebo in different orders as follows, either: 1. Treatment Period 1: Propagermanium capsule twice a day for 12 weeks Treatment Period 2: Placebo capsule twice a day for 12 weeks. OR 2. Treatment Period 1: Placebo capsule twice a day for 12 weeks Treatment Period 2: Propagermanium capsule twice a day for 12 weeks. This study will determine how safe and effective propagermanium is in the treatment of paients with DKD by: • monitoring symptoms that patients may experience while on the study • measuring levels of protein in patients urine and kidney function during the course of the study. • measuring the levels of propagermanium and irbesartan that enters into patients urine and blood • comparing the propagermanium result to patients' pre-study and placebo results

The aim of this study is to determine if an evidence-based parenting program which also teaches skills to cope with everyday stress (Enhanced Stepping Stones Triple P) is more effective than a parenting program alone (Stepping Stones Triple P) in improving the mental wellbeing of both parents and children who experience mental health challenges. For adults, mental health challenges include symptoms of depression, anxiety, hyperactivity, and substance abuse. For children, mental health challenges may include symptoms of depression and anxiety as well as developmental issues including symptoms of attention deficit/hyperactivity, autistic traits and conduct problems.

This study aims to assess the accuracy of continuous interstitial glucose monitoring using two different blood glucose monitoring systems and compare results to conventional methods (finger prick test) in women requiring betamethasone treatment for preterm birth. In usual practice only finger prick testing will occur. In this study the two devices are used on abdomen and upper arm, and an IV cannula is inserted for measurement of blood ketones.

Adverse drug events (ADEs) cause around 2–3% of all Australian hospital admissions at a cost of about AUD$1.2 billion annually, and are the focus of this proposal. Older people are at high risk of ADEs, and we have shown that exposure to medicines that might harm them is very common in older people and can have important clinical consequences. The problem is hard to identify. Many older people may benefit from taking fewer medicines, but doctors rarely stop medicines in older people, even those close to death. There is now good evidence that some medicines can be stopped safely in older people, and that reducing unnecessary medicines has survival benefits for older people. The barriers and enablers to stopping medicines are now well described. However an important gap persists in translating what we know about problem medicines use to inform doctors and patients’ shared decision making around this issue. We have designed the present study to systematically address the known barriers to deprescribing. We will evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) framework to address multiple medicines use in older inpatients taking 5 or more medicines. This randomised controlled trial will compare the AusTAPER intervention to usual care. Addressing multiple medicines use in older people may reduce adverse events and save money. There is evidence to suggest that there will be cost benefits by both reduced medicines costs, and reduced adverse events leading to reduced health service utilisation.

Older people are at high risk of adverse drug reactions. We have shown exposure to potentially harmful medicines is very common in older people, can have substantial clinical consequences, but is problematic to identify. Older people with multiple comorbidities have rarely been included in clinical trials and there is genuine clinical equipoise as to the risks and benefits of many medicines in older people. In addition, there is uncertainty about the validity of the default practice of extrapolating from trial data in younger groups when prescribing to older people. Many older people may benefit from taking fewer medicines, but doctors rarely cease medicines in older people, even those close to death. There is now substantial evidence some medicines can be safely and carefully ceased in older people, with reduction in polypharmacy having survival benefits for older people. The barriers and enablers to deprescribing are now well described. However, an important gap persists in translating the evidence about the benefits of more appropriate prescribing and safety of deprescribing into everyday clinical practice. Currently this body of evidence is not being used enough to inform GPs and patients’ shared decision making around this issue. The present pilot study is designed to investigate the feasibility of an approach to systematically address the known barriers to deprescribing and evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) in addressing polypharmacy. The AusTAPER intervention integrates patient priorities and decision support tools to electronically flag potentially inappropriate medicines, and provides a clinical pathway for structured assessment and follow-up by GPs and community pharmacists in a web-based system. The ‘Team’ in this intervention model refers to the patient (‘participant’), study pharmacist and GP.

This is a study evaluating the safety and maximum tolerated dose of HLX20, a Human Monoclonal Antibody, in participants with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged at least 18 years old and have a confirmed advanced or metastatic tumour, for which treatment has failed or not tolerated. Study details All participants in the study will receive intravenous treatment with the study drug HLX20. The dose may vary depending on when the participant joins the study. Blood and tissue samples will be collected for safety analysis, efficacy and tolerability of HLX20. Additionally, patients may also undergo imaging/scans and a biopsy if archival tissue sample is unavailable. There is no guarantee that you will receive any benefits from this study, and taking part in this study may or may not cause your health to improve. Information from this study may help doctors learn more about HLX20 on the treatment of your cancer