ANZCTR search results

After abdominal surgery, the bowel can commonly be paralysed and slow to return to normal function. The resultant intolerance to food and liquids can result in severe bloating, inability to pass a bowel movement or gas, nausea, and vomiting. This complication of surgery is called post-operative ileus and is a source of discomfort for patients after surgery. In colorectal rectal surgery, this common complication results in the second most morbidity and mortality following an anastomotic leak and doubles the cost of an admission. This study is a double blinded randomised controlled trial to determine if pyridostigmine can be included as part of an enhanced recovery protocol (ERP) to reduce the duration of post-operative ileus following colorectal surgery.

Babies that are born too soon (preterm) are at risk of slow growth and delayed development. This can affect lifelong health. Exclusive breastfeeding and use of breast milk is a key way to improve outcomes for babies born preterm but these babies often have problems breastfeeding and their mothers can find it hard to produce enough milk, especially in the first few weeks after birth. As a result, many are given infant formula, which can be difficult to digest and is sometimes harmful to preterm babies as they are born before their gut is fully developed. Feeding babies with pasteurised donor human milk has been shown to improve health outcomes for babies born very early but we do not know if it benefits babies born just a few weeks early (moderate to late preterm). The primary aim of this randomised controlled trial is to determine whether using donor human milk, instead of infant formula, in the critical early weeks after birth improves nutrition and growth of moderate to late preterm infants, and supports their mothers to continue breastfeeding in the first 6 months after birth. The trial will be conducted in partnership with Australian Red Cross Lifeblood.

This is an open-label Phase II pilot study to investigate the safety and tolerability of two doses of ketamine in young people with stimulant use disorder, methamphetamine-type seeking treatment to reduce their methamphetamine use. The study treatments will be provided in addition to treatment-as-usual received by participants during their regular clinical care. All participants will be engaged with a GP or psychiatrist, either through headspace, Orygen, or in the community, and they will be offered referral into outpatient alcohol and other drug treatment at headspace or in the community. They will receive psychiatric and medical review by the study doctor during screening and at weeks 1 and 2. Participants will complete comprehensive screening and baseline testing. They will then undergo two ketamine administration sessions (subcutaneous; initial dose 0.75 mg/kg) separated by at least 7 days. Assessments will occur at baseline and weeks 2, 3, 4, and 6.

A new approach to therapy for people with aphasia (language impairment after stroke) has been developed by our team which, when compared to usual car in a pilot trial, has provided highly promising evidence of greater gains in everyday speaking, participation in daily activities, and quality of life. The protocol, NARNIA (a Novel Approach to Real-life communication: Narrative Intervention in Aphasia), is a highly structured language therapy delivered using a natural interactive approach. As different service delivery models are in place within clinical settings, i.e. individual 1-to-1 therapy and group therapy, 10 people will receive individual therapy and 10 will receive group therapy. We aim to examine treatment effectiveness in a clinical setting, individual variability, and feasibility of group delivery of this approach.

This trial aims to determine the feasibility, safety, and efficacy of dietary counselling to increase soluble fibre for reducing pelvic radiotherapy-related gastrointestinal symptoms in patients with gynaecological cancer. Who is it for? You may be eligible for this study if you are 18 or above, have been diagnosed with a gynaecological cancer, and are attending the Royal Brisbane and Women’s Hospital (RBWH) for pelvic radiotherapy with curative intent. Study details All participants will be provided with weekly, 45-minute telehealth appointments with a dietitian to discuss strategies for increasing dietary fibre and general nutritional advice, for the duration of radiation treatment. During this period, participants will be asked to maintain a weekly three-day food and symptom diary. Participants will also be provided with a number of questionnaires to complete upon commencement of radiation treatment and at the end of treatment. It is hoped that this study may demonstrate that dietary counselling to increase soluble fibre is feasible, safe, and efficacious in managing radiotherapy-related gastrointestinal symptoms in women with gynaecological cancers.

This is a prospective, cohort study aiming to determine the feasibility of transplanting HCV positive kidneys into HCV negative recipients. The study team will identify potentially eligible subjects from the renal transplant waiting list. The study will be explained to them by both renal and gastroenterology study team members. Adequate time will be given for all questions to be answered to the participants complete satisfaction. Once the informed consent form has been signed, the subjects eligibility will be confirmed. When a HCV positive kidney becomes available, the transplant will occur as per normal practice. As deemed clinically appropriate, as soon as possible after transplant the study subject will be commenced on a direct acting antiviral (DAA) treatment regimen of glecaprevir and pibrentasvir (g/p) for 12 weeks. The subjects normal, renal post-transplant inpatient and outpatient protocols will be followed. In addition, the subject will have follow-up with the Gastroenterology study team and additional blood samples will be taken to monitor HCV status and liver function. In particular, HCVRNA will be monitored until expected HCVRNA clearance at week 12.

The purpose of the research is to determine the feasibility of a home-based program called Kick-Smart Homework. This is an initiative focusing on basic martial arts techniques and mathematics. The program integrates mathematics and physical activity conducted at home, and assessments conducted at school. Based on previous studies, increased participation in Physical Activity (PA) may improve cognitive functioning and academic achievement. Movement can aid learning and the integration of physical activity has the potential to enhance learning and student engagement in other curriculum areas. The Kick-Smart Homework program is a home-based intervention and has the potential, based on the results of previous trials, to motivate and engage students both academically and physically. Students will be asked to participate in 3 x 10 minute sessions of mathematics/martial arts (per week) over a six week period in Term 1, 2021 that promotes moderate to vigorous activity. The martial arts and fitness activities have been specifically chosen to be simple and have no greater risk than any other fitness activity. Exercises involve traditional physical activities such as squats, star jumps, chair dips. push ups etc, or variations of such activities to reflect movements commonly seen in martial arts.

We will undertake an individually randomised controlled trial: effectiveness implementation hybrid type 1 (n=200) to test the impact of a telehealth physiotherapy PA advisory service on physical activity of clients in the target groups. Implementation outcomes will be assessed alongside effectiveness outcomes and will include dose and implementation determinants. The PA advisory service will be staffed by a physiotherapist who will provide support to both health professionals and clients in the target groups to promote PA. The PA advisory service will provide a range of services including motivational interviewing, assistance in locating suitable community activities (in-person and on-line), advice on transport and subsidised/low- cost programs, liaison with community providers and where necessary supporting the person to attend these activities. Assistance for health professionals seeking information on these issues will also be available. Clients in the intervention group will receive services provided by the telehealth physiotherapy PA service. The control group will receive usual care which consists of an information brochure about the NSW Active and Healthy website and the Get Healthy coaching service. Clients in both groups will complete a baseline survey and after 3 months, a follow up survey. The intervention group will also complete an additional survey about their impressions of the intervention at 3 months. Clients will complete actigraph data collection at baseline and 3 month follow up to collect data on PA levels (specifically number of steps/day).

The purpose of this project is to evaluate the movement of immune cells that occur naturally in the clear window at the front of the eye (the cornea). This movement will be evaluated before and after the application of commercially available eye drops used to treat sign and symptoms of mild to severe dry eye. Immune cells with and without dendrites give the immune system the ability to sequester, tightly regulate, and increase the efficiency of defense against internal and external pathogens. Understanding the cell dynamics in healthy individuals will contribute to normative data to future studies on ocular and systemic diseases. In addition to assessing the corneal nerves, corneal confocal microscopy is also capable of detecting dendritic cells. These cells have a distinctive hyper-reflective shape and are located at the same depth of the corneal nerves, at approximately a 50 µm depth from corneal epithelium. Hence, the assessment of these two important ocular structures in a single image offers useful insight into the association and interaction between both; the nervous and immune systems of the ocular surface. The ability to observe and quantify migration rates of dendritic cells in vivo is likely to reveal previously unknown insights into corneal and general pathophysiology and may serve as an effective biomarker to intervention therapies. The dynamics of corneal resident dendritic cells located at the corneal sub-basal nerve plexus may provide a powerful approach to understanding the spectrum of immune and neurological diseases with applications in observational and analytic epidemiology, randomised clinical trials, screening and diagnosis and prognosis. DC dynamics have the potential to also reflect the entire spectrum of autoimmune diseases from the earliest manifestations to the terminal stages. The behaviour of these cells could potentially offer the means for homogeneous classification of autoimmune and systemic disease and risk factors, and also extend our base information about the underlying pathogenesis of immune diseases.

This randomised controlled trial will compare the effect of liberal vs. conservative oxygen therapy on survival and neurological function at six months in adults who are comatose following resuscitation from a cardiac arrest. The study hypothesis is that conservative use of oxygen (giving the smallest amount of oxygen possible to achieve safe oxygen levels in the blood) will increase the number of patients who survive with good neurological function.