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The Effect of Coblation vs Bizact Tonsillectomy on Post-Operative Pain: a randomised control trial
Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. This trial will randomise patients to one of these two methods and study post-operative pain outcomes by visual analogue pain scores and days to normal activity. Bleeding during and after surgery, and the duration of surgery, will also be measured. We hypothesize that coblation tonsillectomy will result in reduced post-operative pain, reduced primary and secondary bleeding during and after surgery, a shorter duration of surgery and faster return to normal activity when compared to the Bizact method.
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Coronavirus in Victorian Healthcare and Aged care workers (COVIC-HA) Cohort Study
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Vaccination of kidney transplant and dialysis patients and their close household contacts against COVID-19
This study aims to measure the efficacy of the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) and BNT162b2 mRNA (Pfizer-BioNTech) COVID-19 vaccines in transplant recipients and patients on dialysis, and in their close household contacts. Early reports indicate that kidney transplant recipients receiving immunosuppressive medications have a reduced protective immune response to COVID-19 vaccines. This is of concern as these are the individuals most at risk. These patient groups are adept at avoiding exposure to pathogens out in the world, and are therefore most likely to be exposed to the SARS-CoV-2 virus via a close household contact e.g. a spouse. In this study, transplant recipients and dialysis patients will receive their vaccination at the same time as a close household contact. By comparing the immune response of patient and cohabitant, we will develop an understanding of whether priority vaccination of household contacts is a worthwhile strategy for protecting transplant and dialysis patients from COVID-19 in the future.
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Effect of pyridostigmine on the duration of post-operative ileus after colorectal surgery.
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.
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Giving donor milk instead of formula in moderate-late preterm infants: the pilot GIFT trial
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.
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Ketamine for methamphetamine use in young people
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.
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Beyond NARNIA: Examining the effectiveness of a novel communication intervention for post-stroke aphasia in the clinical setting
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.
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Dietary counselling to increase soluble fibre in patients with gynaecological cancers undergoing pelvic radiotherapy: a feasibility study
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.
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The REPLACE study - renal transplant of HCV RNA positive donor kidneys into HCV RNA negative recipients: a pilot study
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.
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The Kick-Smart Homework program: A randomised feasibility trial evaluating the feasibility and efficacy of a primary-school based martial arts homework program integrating mathematics and physical fitness.
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.