ANZCTR search results

This study is primarily intended to investigate the safety and tolerability of platelet-derived extracellular vesicles (PLEXARIS) following intradermal injection around a skin punch biopsy in a healthy participant. PLEXARIS will be directly compared to a matched placebo formulation in each participant. Additionally, the study aims to evaluate the time to wound closure between the treated and control biopsies, and assess the presence of scaring, erythema or infection at the wound site.

The study aims to demonstrate that 400 mls of a preop carbohydrate drink is fully cleared from the stomach 2hours after consumption in pregnant patients fasting for a caesarean section. All elective patients are subject to standard fasting guidelines-6h for food and 2h for clear liquid. In an effort to minimise physiological disruption to patients a carbohydrate drink (as opposed to water) has been given to patients fasting for operations. There is minimal data to in the heavily pregnant patient to demonstrate that a carbohydrate drink is cleared from the stomach.

Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed following musculoskeletal injuries and fractures as an effective method of pain relief. However, there is inconclusive evidence that these NSAIDs may impair bone formation, and therefore impact upon fracture healing, creating delayed union or non-union. It is essential that we have solid evidence to inform clinical guidelines on the use of safe and appropriate analgesia to improve patient care. In order to conduct a large multi-site randomised-controlled trial (RCT) to draw more definitive conclusions about the effects of NSAIDs on bone healing, it is important to firstly ascertain the safety and feasibility of conducting such a study via a pilot RCT. Therefore, the aim of the current study is to determine the feasibility of using a prescribed treatment regime of NSAIDs versus a placebo in people with tibial shaft or femoral shaft limb fractures, and is expected to inform the design of a large multi-site trial.

The primary aim of this intervention research project is to investigate the impact of a neck strengthening exercise program on the incidence of concussion in adolescent (12-18 years) contact sport athletes. A secondary aim will be to investigate whether higher neck strength is associated with reduced head acceleration during purposeful heading in adolescent football (soccer) players. Neck muscle strength data will be collected for all participants at three time points (baseline, 6-week, and 6-months) using a hand-held dynamometer along with weekly completion of a concussion incidence and activity survey. Additionally, for football players only, accelerometry will also be used to capture head acceleration during purposeful heading at three time points (baseline, 6-weeks and 6-months). Anthropometry (neck girth, height and weight) data for all participants will also be collected. If higher neck strength is associated with a lower incidence of concussion this evidence would provide an incentive to include neck strengthening exercise as part of all injury prevention programs within these sports.

There is no medical treatment that has been shown to have clinical benefit in primary sclerosing cholangitis (PSC); a condition affecting the liver and bile ducts. Mesalazine (5-ASA) is a first-line medication used for treatment for ulcerative colitis. Ulcerative colitis has a strong association with PSC. 5-ASA is rapidly metabolised before reaching the liver and bile ducts which may restrict its potential benefit in PSC. This study investigates whether a naturally occurring flavonoid, quercetin, may inhibit metabolism of 5-ASA and lead to improved drug delivery to the liver and bile ducts. This study will also explore the impact of quercetin on the bacterial population in the faeces.

This study is a prospective, interventional study of bone health in children with neuromuscular diseases conducted at The Royal Children’s Hospital, Melbourne. The effect(s) of pubertal induction in paediatric neuromuscular diseases have not been formally studied. Our main aim is to provide evidence as to whether pubertal induction may improve bone health and quality of life in children and adolescents with significant neuromuscular disabilities and reduce burden of care on families. Children with neuromuscular disabilities are often very thin and have poor muscle strength and stability, which increases fall frequency and risk of fracture and often have delayed or arrested puberty. Puberty is a crucial time for bone mass accrual and therefore, an optimal time for clinicians to intervene to improve bone health.

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised). Who is it for? You may be eligible for this study if you are an adult who has cancer of the oesophagus or gastro-oesophageal junction that has spread to other parts of your body. Study details All participants in this study will receive 10 treatments of radiotherapy to the primary oesophageal cancer, with one treatment given on each working day for two weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same two weeks as the radiotherapy. Durvalumab, an immune therapy, received intravenously; will be given every four weeks from the beginning of radiation therapy. After this participants will continue to receive immune therapy (Durvalumab), received intravenously once every 4 weeks for up to 24 months or until the cancer worsens. If participants have a metastatic tumour, they will also be given 3 doses of radiotherapy in one week. This radiotherapy will be received 4 weeks after the initial radiotherapy is completed. Safety blood tests will be collected through out the study (every two weeks from week 2 of treatment and then every four weeks from week 9 throughout the treatment and at other times if clinically indicated). Cat Scans to evaluate the response to treatment will be done every 6 weeks up to week 24 of treatment and then every 12 weeks or until the cancer worsens. Study participants will also be asked to complete some questionnaires about their wellbeing and nutritional status periodically through out the study. It is hoped that this trial can help determine if this chemotherapy with immune therapy and radiotherapy combination is effective in increasing the ability of the body’s immune system to prevent worsening of the cancer and improve swallowing.

The main aim of this crossover study is to see whether LAT8881 is safe and effective in relieving acute migraine headaches. Subjects enrolled in the study will be randomised to receive Investigational Medicinal Product (LAT8881 60 mg or placebo), to be taken at the onset of a migraine headache of moderate to severe intensity. Subjects will be given a single dose of IMP, to treat one migraine headache. After treatment of one migraine headache and a 48 hour washout period, the subject will return to the clinic for re-evaluation and crossover to the second treatment.

The aim of this study is to assess the effect of orally-dosed palmitoylethanolamide (PEA) on allergy symptoms in otherwise healthy young males and females aged over 18 years compared to a placebo. This is a double-blind, randomised, clinical trial with a 2-week treatment duration with 2 arms. It is hypothesised that PEA supplementation over a period of 2 weeks will reduce the severity of allergy symptoms compared to the placebo.

This study aims to understand the impact of a nutrition-exercise intervention commenced early during an acute hospitalisation and continued for an extended period post-discharge on frailty. This study will test whether a multi-purpose intervention can be delivered by a trained allied health professional and if successful can have financial benefits in the current times of economic constraints. If found to be effective, it will create a streamlined service that can benefit the increasing population of frail elderly patients.