ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31251 results sorted by trial registration date.
  • The association between looking or smiling at a patient and requests for assistance: A single-centre, blinded, randomised, controlled clinical trial

    There is considerable anecdotal evidence that smiling at a patient while walking past their cubicle increases the number of requests for assistance. This is perceived as a nuisance by some staff who believe they are busy enough and that the assistance should be provided by the patient's attending nurse. Given this perception, some staff deliberately do not look at or smile at a patient as they walk past. This trial will determine if smiling truly does increase requests.

  • Does the use of muscle relaxants during anaesthesia for hip arthroscopies influence the pressure on the perineum?

    Many types of surgery, such as some types of hip replacement surgery, hip arthroscopies or the re-alignment of femoral fractures need to be performed on a traction table. In order to not pull the patient off the operating table when pulling on the leg, a padded perineal post is used. However, once traction is applied, the patient’s pudendal nerve region is pressurized by the post and the nerve can subsequently be damaged. This can result in significant nerve dysfunction which may be short-lived, but can also last for years after surgery. Sexual dysfunction after operations on a traction table is a long-known, but difficult to avoid problem (1-3). Mallet et al.(1) studied 168 patients after either operations on a traction table or a normal (non-traction) operating table. They found a 40.5% rate of erectile dysfunction (ED) in otherwise young, healthy males even years after operations on a traction table. Investigating potential influencing factors, the dose of the muscle relaxant administered during the anaesthetic was the only modifiable factor, with higher doses likely to prevent ED. The authors concluded that good relaxation leading to lower traction forces required and consequentially lower pressures on the pudendal nerve explained the superior outcome after deeper muscle relaxation (1). Though this theory seems logical, it has actually never been proven. Aim of this study is to determine the effect of deep muscle relaxation on the pressure on the perineum by the perineal post during operations on a traction table. Using an ultra-thin (approx.1 mm) pressure sensor foil embedded into the perineal post, we propose to measure the changes in pressures on the pudendal nerve after muscle relaxation. Fourty patients scheduled for elective hip arthroscopic surgery at Joondalup Health Campus and Glengarry Private Hospital will be included in this study. All patients will receive a standard general anaesthetic. After traction is applied on the operated leg, the resulting pressure on the perineum will be recorded. With the applied traction unchanged, the patient then receives a dose of the muscle relaxant rocuronium and the resulting change in pressure will be monitored. This concludes the study. The proposed project will close a significant gap of knowledge and, in a simple and risk-free approach, may lead to a change in anaesthesia practice. In addition, the joint width (hip) wil be measured before and after apralysis using portable xrays. If the joint width increases after the paralysis, the traction on the patients's leg will be reduced until the joint width is back to pre-paralysis status. At this stage the pressure on the pudendal nerve will be recorded again. References 1. Mallet R, et al. Urology. 2005;65(3):559-63. 2. Brumback RJ, et al. The Journal of bone and joint surgery American volume. 1992;74(10):1450-5. 3. Chan PT, et al.The Journal of trauma. 1999

  • An investigation into the immunomodulating effects of Andrographis paniculata in healthy males

    A wide range of animal and in vitro studies have demonstrated that the herbal medicine Andrographis paniculata (AP) possesses immunomodulatory, anti-inflammatory, antioxidant and anti-depressant properties. This pilot trial examining the effects of Andrographis paniculata (AP) will be carried out by researchers from the University of New England (primary investigator - Dr Linda Agnew). They have previously reported that AP induces an immune response via altered stress protein levels in ex vivo studies. A number of other human clinical trials have confirmed that supplementation with AP reduces the severity of symptoms in upper respiratory tract infections. More information is needed however, before a definitive statement can be made regardings its mode of action and efficacy as a herbal medicine. The aims of this small-scale intervention study are to examine the effects of supplementation with AP on parameters of the immune, inflammatory, stress and antioxidant responses. These aims will be achieved by measuring immune, inflammatory and antioxidant markers in blood and saliva samples as well as psychological variables collected from healthy male volunteers taking AP for two weeks at a total daily dose equivalent to 6.0 g dried leaf equivalent. All measures will be taken at commencement of the trial, prior to intervention, and after 14 days of supplementation.

  • Metabolic effects of cross-sex hormone treatment

    Biological differences between males and females are well known in terms of reproductive functioning. However, it is becoming increasingly well recognised that non-communicable chronic diseases, such as diabetes, cardiovascular disease, and many neurological and mental health disorders display sexual dimorphisms in their pathogenesis and presentation. Females are somewhat protected against both the development of insulin resistance and cardiovascular disease compared with males of a similar age. However, this difference between sexes diminishes after women reach menopause. Much of this sexual dimorphism has been attributed to the regulatory effects of the steroid sex hormones testosterone, oestrogen and progesterone. Cross-sex hormones (CSH) are a treatment option used to treat gender dysphoria (DSM V) and facilitate transition from their natal sex (i.e. sex assigned at birth) to their identified gender. Feminisation typically requires administration of androgen-blockers and co-administration of oestrogen hormones, whereas masculinisation requires administration of testosterone treatment. Treatment with CSH is usually lifelong. Evidence shows that transgender persons are at an increased risk of mental distress and chronic disease. In addition to the physical changes induced by cross-sex hormone therapy commonly associated with puberty (such as changes to body hair, skin appearance), cross-sex hormones have been shown to influence factors such as body composition. The overall effect of cross-sex hormone treatment on cardiovascular and diabetes risk is still unclear. Cross-sex hormone treatment has been reported to both improve and impair various CVD risk factors, such as fasting glucose and insulin levels, plasma docosahexaenoic acid (DHA) levels, adipokines and C-reactive protein. Studying the effect of cross-sex hormones on DHA status and other risk factors for CVD and diabetes in transgender persons undergoing hormone therapy allows a unique opportunity to investigate the contribution of sex hormones to the sexual dimorphisms apparent in both these conditions. Furthermore, investigating metabolic changes in response to cross-sex hormone treatment may help to inform dietary and/or pharmaceutical strategies for minimizing the health risks associated with receiving CSH in this at risk group. Therefore the aim of this observational study is to measure the effect of cross-sex hormone therapy on metabolic risk factors for both diabetes and CVD in transgender individuals undergoing hormone therapy.

  • The Effect of Gut Sterilisation on the Prevention of Progression of Portal Hypertension in Cirrhosis.

    The primary purpose of this trial is to assess the effectiveness of Rifaximin in preventing variceal bleeding (bleeding from enlarged veins due to increases in blood pressure) in at risk patients and to determine the effect of Rifaximin on gut bacteria. Who is it for? You may be eligible to participate in this trial if you are aged 40 or over with compensated cirrhosis (chronic liver disease) and are at high risk of variceal bleeding. You must be unable to take propranolol (a blood pressure medication) or have declined this treatment for variceal bleeding to be eligible for this trial. You are also eligible for the trial if you have recently commenced or are continuing with endoscopic variceal ligation (EVL - is a procedure where enlarged veins in the oesophagus are tied off using a rubber band) as preventative treatment for variceal bleeding. Study details All participants enrolled in this trial will receive Rifaximin. Before treatment begins, you will need to undergo a hepatic venous pressure measurement and provide a stool sample, so that your treating team of clinicians will be able to compare portal pressure (blood pressure in the liver) before and after Rifaximin treatment and determine the effectiveness of this new treatment. Treatment period will be for 6 months, where you will have to take one Rifaximin pill (each 550mg) twice a day, with or without food, every day until the end of the treatment period. You will need to return to your doctor’s office in the middle of the treatment period (3 months) to provide a stool sample, collect your next cycle of drugs and complete standard of care treatment for your cirrhosis. At the end your treatment, you will have to return to the hospital for some follow up procedures to determine the effectiveness of the treatment drug, Rifaximin. These procedures will include a repeat hepatic venous pressure measurement, an endoscopy and a proctoscopy to observe size of varices and obtain biopsy samples, and a stool sample. The biopsy samples, a duodenal and rectal biopsy, will be obtained to determine whether Rifaximin changed gut bacteria and if this had a role in treatment outcome. Post-treatment all participants will be asked to provide a stool sample at 12 months, so that the doctor can ensure that your bacteria is back to normal. We hope that Rifaximin will provide an alternative treatment option that may be better at controlling inflammation of the liver and reducing portal pressure that results in bleeding, without the associated side effects, compared to current treatment options. It is hoped that the findings from this study will help optimise treatment management of patients with cirrhosis.

  • The effect of two local anaesthetic techniques on pain scores during and after intravitreal injection

    We performed a prospective randomized clinical trial to compare the pain experienced by patients who undergo either topical pledget or subconjunctival injection anaesthetic prior to intravitreal injection. 112 patients were recruited, randomised, blinded to anaesthetic method and administered either a topical pledget anaesthetic with 0.5% amethocaine hydrochloride or a 2% lignocaine subconjunctival injection. 5 minutes after intravitreal injection, a Visual Analog Scale was used to determine pain and this was repeated at 24 hours post injection via phone. 67 patients returned to the clinic and underwent the opposite anaesthetic technique for their next intravitreal injection. Pain scores were repeated at 5 minutes and 24 hours post injection. Patients were asked whether they preferred the first or second injection. Median pain scores out of 10 were low in both groups, but median 5 minute post injection pain was significantly lower in the subconjunctival injection group compared with the topical pledget group (SC= 1/10, TP= 2.5/10, U=1063, z=-2.97, p=0.003, r=.28). No significant difference in pain was evident in 24 hours post injection. 24 hour pain scores were significantly higher in those who had less than 10 previous injections (p=0.005). The preferred injection was subconjunctival injection in 75% of patients who had a repeated injection. SCI over TP anaesthetic may provide a superior modality of pain relief for intravitreal injections.

  • Management of Diabetic Foot Ulcer by Electromagnetic Stimulator Therapy at The Townsville Hospital –A Pilot Study

    Electromagnetic stimulator therapy (EMST) is a new technology in the care of chronic non-healing wounds [1]. The technology delivers high-energy pressure waves into the wound by enriching the ulcer with adequate blood through formation of new blood vessels. It also stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound [2]. Recently, EMST was reported to be effective in the initiation and acceleration of wound healing in various non-diabetic clinical settings most part involves small case series of bed sores and venous ulcers with scanty reports on diabetic wounds [1-2]. Thus, there is very little information on effect of electromagnetic stimulation in healing ulcers of diabetic foot. With our earlier report of high rate of diabetic limb amputations in our local population [3-4] we believe EMST technology may have a role to play in the care of our patients. This technology is simple and can be administered fortnightly as against daily administration in other form of therapies. The treatment with EMST is a non-invasive method and easily tolerated by patients. It is applied through an unfocused applicator which assures an almost painless treatment and no anaesthesia required. Each therapy session only takes about 15 to 60 minutes. As EMST being a viable option of diabetic foot ulcer (DFU) care in our high risk diabetic population yet there is no study to show EMST usefulness in treatment of non-healing DFU in Australia. It would be interesting to find out if this technology would change our current daily diabetic foot ulcer care practice for the betterment of the most costly diabetic complications -DFU. The main objective of the study was to evaluate the healing rates of chronic diabetic foot ulcers during a 12-week period in patients treated with EMST and usual care compared to usual care alone. Reference 1. Gaurav Thakral et al. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013; 4: 10.3402/dfa.v4i0.22081. 2. Jhamb S, Vangaveti VN, Malabu UH. Genetic and molecular basis of diabetic foot ulcers: Clinical review. J Tissue Viability. 2016. pii: S0965-206X(16)30041-9. 3. Rodrigues BT, Vangaveti VN, Malabu UH. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study. J Diabetes Res. 2016;2016:5941957. 4. Gilhotra RA, Rodrigues BT, Vangaveti VN, Kan G, Porter D, Sangla KS, Malabu UH. Non-traumatic lower limb amputation in patients with end-stage renal failure on dialysis: an Australian perspective. Ren Fail. 2016 Aug;38(7):1036-43.

  • Building Better Readers: testing the value of MiniLit for Year 1 students with low reading ability

    A number of studies have examined the impact of the MiniLit program on the reading ability of students participating in the program. Although these previous studies have shown promising benefits in terms of effect sizes on children’s reading (d = 1.1 to 1.8), results are derived from differences between pre- and post-training scores. In addition, there has been limited efficacy and effectiveness studies that compare children who complete MiniLit to those who receive “business as usual” classroom teaching or alternative RTI Tier 2 interventions. The current evidence for MiniLit consists of studies performed by the developer, including a small within-school, wait-list randomised controlled trial of the MiniLit program demonstrating its positive impact (5-8). Therefore, these promising findings now need to be evaluated in a large scale RCT to determine the impact of the program on student outcomes when scaled to system-level implementation. In addition, it is important to evaluate the process indicators that can predict the outcomes of the intervention, as well as the implementation cost-benefit. The overarching question of this project is whether the MiniLit intervention, offered to Year 1 students identified as being in the bottom 25% of readers, improves student reading and literacy outcomes 12 months post-randomisation? The primary research aim of this project is: 1To determine, for Year 1 students in the bottom 25% of readers, whether students who receive MiniLit have better reading outcomes at 12 months post-randomisation, compared to those who have usual classroom teaching We therefore hypothesise that students who receive the MiniLit intervention will have better mean reading ability scores on the Australian Edition of the York Assessment of Reading for Comprehension - Passage Reading (YARC – PR) at 12 months post-randomisation, compared to students who receive ‘business as usual’. The secondary aims are: 1. To determine student reading outcomes in both intervention and control groups 6 months (short term) post-randomisation. 2. To determine the proportion of students with ‘low reading ability’ in both intervention and control (‘business as usual’) groups at 6 and 12 months post-randomisation 3. To determine the implementation enablers and barriers that are predictive of program success and sustainability 4. To determine the cost per student, and cost-effectiveness of the intervention

  • Evaluating the efficacy and feasibility of a university-based high intensity interval training program (Uni HIIT) on health and well-being in young adults

    The overarching aim of this study is to investigate the impact of a unique HIIT program (Uni HIIT) on cardiorespiratory fitness (primary outcome), physical activity, body composition, stress,executive function, well-being and psycho-social health outcomes in low active young adults when implemented in university settings. Using a randomised controlled trial (RCT) the Uni HIIT program will be implemented Phase 1: single site RCT at the UoN (n=60)

  • Omega-3 fish oil for the prevention of Gestational Diabetes

    Gestational diabetes (GD) is a form of diabetes which occurs during pregnancy, and generally resolves after delivery. It is diagnosed as high blood glucose during pregnancy, and affects around 5–10% of all pregnancies in Australia. Recent changes to diagnostic criteria along with an increasingly obese population and older age at which women have their first child, mean the prevalence of GD is rapidly rising. Pregnancy is known to be an insulin-resistant state, and failure to adequately compensate for this inherent insulin resistance through increased insulin secretion results in hyperglycaemia. Whilst the precise mechanisms behind this insulin resistant state are unclear, there is increasing evidence that inflammation of adipose tissue is associated with GD development. Pregnancy is characterized by adipose tissue remodeling and growth, which is modulated by inflammatory markers. However, higher levels of inflammatory markers such as IL-6 and TNF-a, and lower levels of adiponectin are associated with the development of GD. Docosahexaenoic Acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3PUFA) that is critical to the neural development of the foetus during pregnancy, and may be beneficial to adipose tissue functioning during pregnancy. Pregnancies complicated by type 2 diabetes and GD are associated with a decline in erythrocyte DHA in late pregnancy when compared with normoglycaemic pregnancies. This fall can be ameliorated by DHA supplementation during pregnancy. Supplementation of n-3PUFAs in pregnancies affected by GD confers beneficial effects on insulin resistance when compared with control groups Furthermore, supplementation of EPA + DHA from weeks 10-16 of pregnancy until term results in reduced expression of IL-6, IL-8 and TNF-a in both adipose and placental tissue. The improved insulin sensitivity and adipokine profile and reduced levels of inflammatory markers suggest improved adipose tissue function in response to n-3PUFA supplementation, which could reduce the risk of developing GD. To date, research investigating the relationship between n-3PUFAs and GD as an outcome have not reported a relationship. However, supplementation in these trials commenced later in the second trimester, from 17 weeks’ gestation, with the majority not commencing until 24 weeks gestation. We postulate this is too late in pregnancy as GD has often become apparent by this point. No research has reported the effect of an n-3PUFA intervention in early pregnancy on insulin resistance, adipokines and markers of inflammation. We hypothesize that DHA supplementation supports healthy adipose tissue development and functioning during pregnancy, and this in turn reduces the risk of developing gestational diabetes. The aim of the current study is to determine the effect of a low-dose DHA-enriched n-3PUFA supplement on measures of insulin resistance, adipokine profile and inflammatory markers from early pregnancy in women at high risk of developing GD.

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