ANZCTR search results

This study compares the effects of a specialised nutritional supplement to boost the immune system compared with the standard formula, both before and after surgery, in people undergoing major surgery for oesophageal cancer. You can participate in this study if you are scheduled to have oesophagectomy or oesophago-gastrectomy for oesophageal cancer. Participants will be randomly divided into one of four groups. One group will receive a nutritional supplement with added immunonutrition (IN) pre-surgery and the standard isocaloric nutritional supplement post surgery. A second group will receive IN both before and after surgery. The third group will receive the standard supplement prior to surgery and IN following surgery, whilst the fourth group will receive the standard formula both before and after surgery. Patients will be monitored at 7 and 1 day before surgery and 14 and 42 days after surgery. The study aims to see whether the IN product before and/or after surgery will decrease the rate of infective and non-infective complications that often occur in people undergoing this surgery.

This study aims to to determine if the addition of contingency management (CM) to a brief motivational intervention (Quik-Fix) improves treatment retention and outcomes in young people who use cannabis. A randomised controlled trial (RCT) will be conducted to compare the mental health, substance use, and functional and treatment outcomes of 40 young people who receive Quik-Fix only to 40 young people who receive the Quik-Fix + CM intervention. Participants will be followed up at 3, 6 and 12 months. Methodology Participants will consist of 80 young people who have used cannabis at least weekly for the previous one month period. Participants will be provided with a two session Quik Fix brief motivational intervention. It is individually administered and incorporates motivational interviewing, and cognitive-behavioural skills delivered within a harm minimisation framework. A three-track incentive CM system will be used to increase participant attendance and abstinence from drug and alcohol use. 40 participants will be allocated to the Quik-Fix only group and 40 will be allocated to the Quik-Fix + CM group. It is hypothesized that young people receiving the Quik-Fix + CM will have reduced substance use, depressive symptom and improved functioning outcomes, as well as improved treatment attendance, completion and attendance, compared to those receiving Quik-Fix only, at 1, 3, 6 and 12 month follow-up.

Autism spectrum disorders (ASD) are the second leading cause of disability among Australian boys. Despite this, for many years we have lacked an understanding of the brain impairments that underlie autism, and accordingly we have no biomedical treatments that target the core symptoms. A promising new biological explanation that has emerged within the past decade is the “mirror system hypothesis” of autism, which states that brain regions and neurons devoted to understanding other people, which are known as mirror systems, are deficient in ASD. This study will investigate whether mirror system activity in individuals with ASD can be improved using transcranial direct current stimulation (tDCS). tDCS is a safe and non-invasive method of brain stimulation that can be used to modulate brain activity via electrodes that are placed on the scalp. The study will include 20 individuals with an ASD (either high-functioning autism or Asperger’s disorder) and 20 healthy controls. Participants will attend 3 sessions at the Alfred hospital. During each session participants will undergo assessment of mirror system activity using transcranial magnetic stimulation (TMS) after undergoing 20 minutes of tDCS. Each session will involve a different type of tDCS (anodal, cathodal, and sham/placebo). To determine the effect of tDCS, mirror system activity will be compared within ASD and control groups across the 3 sessions. This research is a significant and novel investigation into an economical and well tolerated method for enhancing brain activity. This may provide an exciting avenue for developing treatments for ASD, a significant direction given the current lack of biomedical treatments for this group of debilitating disorders.

This proposed two-phase study is focused on improving nutritional intake in residents with cognitive impairment via a pilot randomised controlled trial of an intervention shown to increase intake. Phase one involves the collection of baseline data from the residents, identification of current meal time practices and family preferences for feeding interventions within the RACF. Phase two involves implementation of an intervention to improve nutritional intake of residents from baseline findings and determine if these interventions are efficient and effective.

There is currently an epidemic of caesarean sections performed in Australia and overseas. Although many caesarean sections are performed for concerns about fetal welfare, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short- and long-term risks, could have been avoided, without compromising the baby’s health. In this study, half the babies with a non-reassuring heart rate recording during labour will have a blood test to measure lactate and the other half will not. We will then determine whether having a lactate test makes a difference in the number women having caesarean births.

Chronic sinusitis affects up to 20% of the population with a significant impact on quality of life for the sufferer. Endoscopic sinus surgery is currently the treatment of choice for chronic rhinosinusitis which fails to respond to medical therapy. This usually involves a combination of oral antibiotics, oral and topical steroids, and saline irrigation of the nose. The main complaint which patients have from this type of surgery is the discomfort and pain associated with debridement of the sino-nasal cavity following surgery. The main cause of failure of this surgery which may require revision surgery is poor wound healing with the formation of excess scar tissue in the form of bands between sides of the nose, called adhesions. Regular wound debridement to achieve the best outcomes following ESS has been strongly advocated, but the basis is largely empirical. Experts in the field have called for regular cavity debridement. There is no standardized regime for post operative care amongst ESS surgeons. In some cases debridement as frequently as daily during the early healing phase has been used. Weekly debridement for the first few weeks until healing occurs is still commonly employed. Sinus cavity debridement is uncomfortable and unpleasant for patients. It requires regular visits to the treating surgeon, with considerable cost implications on the patient and the health service. The literature as it stands is conflicting. There is only 1 pilot study investigating 17 pts in a non-blinded fashion. This pilot study demonstrated no significant difference in adhesions, however this was non-blinded and involved only 17 patients. There are studies that point to early debridement as key to limiting adhesion formation, whereas other studies show that minimal post-operative care is equally successful. The aim of this study is to ascertain whether early debridement, with its related costs and patient discomfort, limits adhesion formation as evaluated by a blinded observer, via video-endoscopy at 3 months post surgery.

The study aimed to evaluate a brief intervention for a young population of cannabis users with comorbid mental health disorders. It was intended that this would serve as an adjunct to treatment-as-usual for the mental health disorder, with the goal to reduce cannabis use behaviour and to reduce disability associated with cannabis use. The intervention involved a motivational interviewing (MI) enhanced CBT treatment. The brief MI-enhanced CBT intervention was evaluated by comparison to a delayed treatment control (DTC) condition. The DTC group was offered the treatment after the completion of the 3 month follow-up assessment. Approximately one week after baseline assessment, the treatment group commenced their first of three weekly sessions, which lasted approximately one hour. Session one involved a discussion of a personalised feedback report which was based on the data gathered from assessment. This feedback was delivered in a motivational interviewing style which aimed to explore ambivalence and promote problem recognition and enhanced motivation to change. Clinical sessions two and three focused predominantly on CBT skill building. Session two focused on understanding the concept of how situations, thoughts, feelings, physical sensations, emotions and behaviours interact and goal setting. Motivational interviewing was used, when applicable. Session three primarily aimed to review prior skills learnt, examine homework outcomes, maintain/build motivation to change cannabis use behaviours, and train in additional coping skills (e.g. managing cravings, dealing with rationalizations, and relapse prevention). Follow-up assessments were conducted at 1- and 3-months post-baseline. These follow-up interviews were conducted by an independent research officer. The DTC group was offered the treatment after they completed the 3-month follow-up.

Glucosamine sulphate is a supplement that is marketed as a joint builder. Potential benefits include: restoration in joint function, an increase in joint flexibility, and alleviation of joint pain. Previous investigations into glucosamine sulphate have found it to have a positive effect on cartilage regeneration within the knee joint, along with a lower incidence of adverse reactions when compared to other over the counter medications used to treat knee pain, such as non steroidal anti-inflammatory drugs. This study will aim to determine whether oral supplementation with a product containing GS is effective in reducing pain and improving physical function of the knee joint in young people suffering from “regular (once a week), mild, undiagnosed knee pain”. Male and female participants aged between 18-35 years of age will be recruited and randomly allocated into one of two groups: 1. Glucosamine sulphate containing product 2. Placebo (Maltodextrin, which is has no published effects on joint function) The trial will last for 8 weeks, and a number of measures will be employed during this time to assess the effects of the glucosamine sulphate supplementation e.g. a daily log of medication usage and physical activity.

Rehabilitation after total hip replacement is important for recovery; at the Canberra hospital physiotherapy provides this rehabilitation. As physiotherapists we don’t know yet how long, what kind or when rehabilitation is most effective. Our own survey showed that only 50% of Australian hospitals offer rehabilitation for hip replacements at all. The project aims to see how effective rehabilitation is by measuring patient outcomes after their total hip replacement surgery. This is a randomised controlled trial with division into two groups after total hip replacement. Group one will receive rehabilitation in the form of the current supervised exercise class and group two will receive a home exercise program to be performed independently. We hypothesise that rehabilitation provided via a home based exercise program without formal supervision after hospital discharge, relying on patient compliance, will produce similar outcomes to those produced by the current method of rehabilitation for total hip replacement patients after hospital discharge, which is that of a centre based program with formal supervision.

The purpose of the SPICE Pilot RCT is to obtain preliminary data on the feasibility of conducting a large phase III RCT. The hypothesis of the proposed RCT is that a sedation regimen based on dexmedetomidine as the primary sedative agent, and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes.