ANZCTR search results

This project aims to assess the feasibility, safety, and potential efficacy of oral cannabis oil in relieving pain and other symptoms in people with fibromyalgia syndrome (FMS). Thirty-six patients (n=36, allowing 20% attrition) diagnosed with FMS will be recruited to take part in a 16-week double-blind, randomised, placebo-controlled trial. Eighteen patients will be given a product containing cannabis oil; the other 18 participants will receive a placebo oil similar in look, taste, and smell. Due to intra-variability of participants metabolism and response to cannabis, an initial slow increase of dose will occur for the first 4 weeks to establish the tolerated dose for that participant. They will then take that dose for another 12 weeks to examine its effects on pain and other symptoms associated with FMS such as sleep, mood, and quality of life.

This study looks at the use of the nasogastric tube in the management of small bowel obstruction in patients with a history of abdominal surgery. The null hypothesis is that not using the nasogatric tube results in an more operations than the nasogastric tube. Small bowel obstruction is a surgical emergency and at its worst can result in the death of a patient due to small bowel infarction. The accepted standard of care is insertion of a nasogastric tube to decompress a distended stomach. There is little if any research evidence to support this practice and this study seeks to compare this practice to not using a nasogastric tube and observe if it results in less patients having srugery to the condition.

This study will investigate whether a drug called budesonide is tolerable and as effective as the standard drug prednisolone in reducing the immune system to prevent organ rejection following liver transplantation. Enrolled participants will be randomly placed into two groups. In the control group, participants will be given standard immunosuppression with prednisolone following their liver transplant. In the intervention group, participants will be given budesonide instead of prednisolone. We will compare rates of organ rejection and differences in infectious, metabolic, musculoskeletal, endocrine and psychological complications between the two groups. We predict budesonide will be comparable to prednisolone in preventing organ rejection following liver transplantation, whilst resulting in fewer side effects.

The aim of this pilot study is to investigate whether moderate intensity exercise could increase neuroplasticity in people with chronic stroke. We specifically investigated people with chronic stroke to avoid the initial, brief, spontaneous period of enhanced neuroplasticity that emerges early after stroke. To evaluate capacity for neuroplasticity, we used a repetitive stimulation protocol, known as intermittent theta-burst stimulation (iTBS) which has been shown to modulate the efficiency of synapses within the cortex. Physiologically, this can be quantified as a change in cortical excitability. Therefore, the hypothesis was that if moderate intensity exercise increases capacity for neuroplasticity, then the physiological response to iTBS would be greater compared to people who do not undertake exercise. If moderate intensity exercise does increase neuroplasticity in people with stroke, then it might provide one method to explore as a technique to re-open a period of enhanced neuroplasticity. Future trials could use exercise as a brain priming therapy to increase responsiveness to rehabilitation.

The purpose of this research trial is to compare the long-term effectiveness of two weight loss programs involving a severe diet. A severe diet is defined in this research trial as a medically-supervised diet that induces fast weight loss (approximately 0.5 to 2 kilograms per week), achieved by replacing all regular meals and snacks with nutritionally replete meal replacement products, such as shakes. Research reveals surprising benefits of severe diets, including: motivation associated with fast weight loss; hunger control; pain reduction; and mood improvements, among other benefits. However, keeping weight off after a severe diet – or indeed after any weight loss diet – is difficult for most people. This research trial will compare two weight loss programs that involve a severe diet. The two weight loss programs are referred to in this research trial as ‘Program 1’ and ‘Program A’. Both weight loss programs are 53 weeks (12 months) in duration, and both involve up to 16 weeks (4 months) on a severe diet. Both weight loss programs are expected to be equally effective for weight loss in the short term (26 weeks, which is 6 months). We do not yet know whether one of these two weight loss programs will be more effective for weight loss in the long-term (53 weeks, 104 weeks, 156 weeks and 260 weeks, which is 12 months, 24 months, 36 months and 60 months).

Contact lens discomfort and its associated dryness are the primary reason to discontinue using contact lenses. In addition, users with decreased tear volume are more prone to be intolerant to soft contact lenses. The lipids of the tear film are produced in the meibomian gland in the eyelids and this lipid is delivered from the meibomian gland to the eye to form part of the tear film lipid layer. This layer promotes tear film stability and prevents drying of the ocular surface. Several of these lipids help stabilise and spread tears across the ocular surface and retard tear evaporation. The amount of lipids in tears is reduced in people with dry eye, and dry eye is related to contact lens comfort. Contact lens discomfort is worse when people’s meibomian glands are blocked. Therefore, we hypothesize that adding lipids back to the eye during contact lens wear will help form a stable tear film and reduce dry eye sensations. We and many others have shown that delivering components from contact lenses is preferable to delivering by eye drops as more of the component remains on the eye. We have produced lipids in the form of small particles that are stabilized using a surfactant compound, and shown that these can be imbedded into contact lenses. A small-scale study has shown that these lipid-containing contact lenses do not increase redness or other clinical measures associated with toxic responses. Now, we would like to test these lenses in a larger study and measure whether lens wearers can notice an improvement in symptoms during wear. In this study, participants will randomly wear lipid-imbibed lenses (O-L), control lenses that contain only the small particles of surfactant with no lipid (C-L), and normal commercially available contact lenses (M-L). The same lens will be worn in both eyes, all participants will wear all 3 lens types (in total 7 visits), and the lenses will be randomly assigned for wear. The primary endpoint is the changes in the tear break-up time, tear evaporation rate, and lipid layer thickness of contact lens wearer over the 8 h of lens wear. The secondary endpoint is the changes in the ocular surface and eyelids of the contact lens wearer over the 8 h of lens wear. The changes in the ocular surface will be investigated by corneal and conjunctival staining and Slit-Lamp Biomicroscopy. The objectives will be a) to measure the comfort response of people wearing lipid-imbibed contact lenses (O-L) vs control lenses (C-L) vs commercially available contact lenses (M-L). b) to measure tear break-up time (tear stability) during contact lens wear of the lenses. c) to measure and evaluate tear lipid layer thickness during contact lens wear. d) to measure corneal and conjunctival staining after contact lens wear.

The full blood examination (FBE) test is the most requested pathology test in Australia, and yet, remote Northern Territory (NT) communities do not have timely and reliable access to this fundamental test. This project aims to improve patient access to full blood examination (FBE) testing in remote primary care facilities through implementing a novel point-of-care (POC) FBE testing device (Therapeutic Goods Administration [TGA] Approved) and its delivery model in the NT using a stepped wedge cluster-randomised trial in 21 primary health care centres. The delivery model will primarily be evaluated for its clinical and cost-effectiveness in the early treatment of sepsis. Other conditions to be explored in a include anaemia, chronic kidney disease and respiratory infections.

The objectives of this feasibility pilot study are to investigate whether pre-operative physiotherapy education delivered via digital video has similar acceptability and treatment fidelity as face-to-face pre-operative education and to pilot the conduct of a randomised controlled trial comparing these two modalities. This study will provide preliminary data to guide the design of a more definite study evaluating the clinical effectiveness of digital versus face-to-face education.

The Sleep Course is a remotely-delivered psychological treatment that has been designed to help people improve their sleep and waking patterns, and daytime functioning (e.g. fatigue, emotional wellbeing). It is designed for adults who report sleep difficulty. It involves four lessons delivered over a 6 week period. Participants also receive telephone support from trained psychologists. The aim of our study is to evaluate the efficacy of the Sleep Course in a group of diverse individuals who experience a sleep difficulty. We hypothesise that people in the Sleep Course will report improvements across the outcome measures.

Constipation after surgery is common and causes bother for patients. This study aims to investigate whether the use of an over-the-counter laxative (scientific name Macrogol) helps to prevent constipation in patients undergoing a gynaecological laparoscopy for non-cancerous reasons. Participants will be given either the laxative or a placebo for 7 days. It is a double-blinded randomised controlled trial which means the participants and research team will not know which treatment has been assigned. Constipation rates and side effects will be assessed with patient questionnaires upon entering the study, and at 7 days and 6 weeks following surgery.