ANZCTR search results

The study aims to collection information on the performance of the robot system intra-operatively. Enrolment is eligible candidates undergoing primary Total Knee Arthroplasty using a Persona total knee implant system or Vanguard total knee implant system or NexGen total knee implant system. There will be three research centres. One surgeon at each centre. Ten participants will be recruited at each centre.

The aim of this study is to investigate the utility of Compassionate Mind Training (CMT) for ex-service personnel with PTSD and their partners, and determine if the training has an impact on compassion, psychological symptom severity, quality of life as well as relationship satisfaction. Four CMT programs will be run between August and December 2018. Group sizes will be limited to 10 participants (5 dyads) in total. Following consent, participants will undertake a 2-hour CMT session, twice weekly for 6 weeks (12 sessions in total) within a group setting. Couples will attend these sessions together. These sessions will be facilitated by two clinical psychologists who are trained and experienced in the delivery of CMT interventions, as well as experienced in delivering group interventions with ex-service personnel. Evidence from prior CMT interventions demonstrates that on completion of a CMT intervention, participants see an increase in compassion and a reduction in psychological symptoms. As such, it is expected that ex-service personnel and their partners may experience an increase in compassion towards themselves and towards others as well as a potential reduction of psychological symptom severity including PTSD, depression and anxiety. Findings of this study will also inform the feasibility of conducting a larger controlled trial of CMT for ex-service personnel and their partners, as well as the application of compassion focussed interventions more broadly to the veteran population.

A rise in systolic blood pressure at the end of dialysis treatment compared to the beginning is associated with increased mortality during follow-up. This observational study aimed to see whether adjusting the dialysate sodium such that it matched the patient sodium helped to prevent significant rises in blood pressure during treatment, without causing undesirable falls in blood pressure. Matching of patient and dialysate sodium will be accomplished by adjusting the dialysate sodium so that the blood sodium concentration leaving the patient to go through the dialyser is the same as that re-entering the patient after its passage through the dialyser. Our hypothesis is that individualising the dialysate sodium in this way will reduce blood pressure problems during the dialysis treatment and may improve thirst.

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.