ANZCTR search results

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of both single and multiple oral doses of an already approved drug called etifoxine. This study will run in 2 stages and involve approximately 30 participants in total. Stage 1 will evaluate the pharmacokinetics, pharmacodynamics and safety of single doses of etifoxine. This stage will enrol approximately 12 participants into a crossover design study where they will receive either etifoxine as a single dose or a placebo at the first visit and then they will receive the opposite intervention at the next visit 7 days later. Stage 2 will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of etifoxine. This stage will enrol approximately 18 participants who will be randomised to receive either etifoxine or a placebo given every 12 hours for 7 days.

The primary aim of this study will be to determine if a pre-operative questionnaire, the ARISE tool, can predict discharge destination to home or inpatient rehabilitation following primary total knee replacement surgery. Existing tools have been criticised for not being predictive of "moderate" scorers, only predictive of those scoring in the high or low range categories. The ARISE tool is designed to capture additional information around a patient's beliefs rather than demographic features such as age and gender etc alone.

Friedreich ataxia (FA) is a chronic, progressive, and terminal illness. Currently, there are no effective treatments and no sensitive biometrics of illness progression for FA. Oxidative stress has been proposed as a candidate molecular process that contributes to the underlying neuropathology, and/or reflects the cellular dysfunction underlying this disease. Measuring and tracking oxidative stress in the human brain using Positron Emission Tomography (PET) provides an opportunity for in vivo mechanistic characterisations disease in the human brain, and represents a novel and potentially sensitive approach to addressing the urgent need for pharmacodynamic and treatment monitoring biomarkers for use in clinical trials. The current study aims to investigate 64Cu-ATSM PET as a tool for imaging oxidative stress in the brains of individuals with FA.

In today's society, snacking has become a regular activity that is affecting the food views and lifestyles of many adults. Regular snacking may simply be the way an individual consumes what they require. But others are consuming snacks that are of poor nutritional value and high in sugar and fat. These types of “snack” foods are being consumed more often and these poor eating habits increase the likelihood of weight gain. We hypothesise that it is this type of snacking behaviour that can be targeted to improve weight mangement for those individuals motivated and able to limit the consumption of snack foods.

MenGO is a Phase III open-label randomised control study in gay and bisexual men, comparing the incidence of gonorrhoea infection in those vaccinated with Bexsero® to those who do not receive the vaccine. The study will test the hypotheses that a reduction in number of gonorrhoea infections will be seen following vaccination with Bexero. It will also investigate Bexsero®-induced antibodies that will inform rational novel vaccine design and show that Bexsero® is a safe vaccine for administration in GBM aged 18-50 years.

This is a randomized, non-inferiority, non-blinded, clinical trial with the two treatments StrataXRT and Mepitel Film being compared within each patient. The purpose of this trial is to determine if StrataXRT is as good as Mepitel Film in reducing the severity and duration of radiation-induced dermatitis,

To determine whether a virtual reality (VR) game of snakes can improve the ability of people with convergence problems to converge as compared to conventional clinical method, and whether is can improve the compliance to treatment. Young adults with convergence problems were pseudo-randomly treated with either the VR Snake game or conventional therapy for three 20 minute sessions per week for 6 weeks. Compliance was assessed as time spent completing the training activities.

Administration of antenatal corticosteroids to women prior to preterm birth has been one of the greatest success stories of modern pregnancy and newborn care. Multiple studies have demonstrated a reduction in the rate of breathing problems in newborn babies after this treatment. More recently, several studies have reported benefits when antenatal corticosteroids are given to women who give birth by elective caesarean section after 35 weeks. Elective CS, as opposed to vaginal birth (or even CS in labour) is associated with greater risks of breathing problems in newborn infants and this results in longer hospital stays and separation from the mother. Women with diabetes were specifically excluded from the studies that have demonstrated improvements in the rate of newborn breathing problems, hence, whether these benefits are the same for infants born to women with diabetes is uncertain. Further research in the subgroup of women with diabetes during pregnancy is urgently needed. This study has been designed to determine the feasibility of undertaking a much larger multicentre, randomised, placebo controlled trial to investigate the outcomes for the mother and baby following antenatal administration of corticosteroids within 7 days prior to elective CS in women with pre-gestational or gestational diabetes. A sample size of 2200 participants will be required for the larger trial. In order to determine the feasibility of such a large study and ensure the collection of appropriate outcome data, we are undertaking a smaller pilot feasibility trial to determine patient and clinician acceptability for such a trial.

Tonsillectomy is the most commonly performed otolaryngologic procedure. Despite advances in surgical techniques, the morbidity post-tonsillectomy remains high especially in the adult population. Pain remains the most consistent and incapacitating symptom experienced by patients post-operatively. This includes the need for analgesics as well as the inability to resume normal diet and activity for several days. Severe pain has been reported in 20% to 50% of children and young adults who have undergone tonsillectomy. There have been many studies investigating a variety of factors that influence post-tonsillectomy pain in the aim of reducing post-operative morbidity and requirement of rescue analgesics such as opiates, which can also have devastating effects. Hypothesis: For many years it has been suggested that post-tonsillectomy pain is further worsened by colonisation of tonsillar fossae with organisms that induce inflammatory response thereby making pain worse. Intervention: We aim to determine if using a probiotic gargle (Streptococcus salivarius) for 14 days post surgery reduces pain and reduces usage of rescue analgesics such as endone. Streptococcus salivarius is already established in the human oral cavity a few hours after birth and remains there as a predominant commensal inhabitant. This product comes in powder or lozenge form and is recommended for daily use. We aim to use the probiotic in powder form as a gargle to maximise contact with affected area (i.e. tonsillar fossa). The comparison group will use a placebo gargle (isomalt). A daily post-tonsillectomy diary will be sent daily via email or mobile phone to patients to complete. Patients who do not have access to email or mobile phone will be provided with hard copy of the questionnaire. If probiotics can reduce post-operative complications in adult tonsillectomy patient patients we would reduce morbidity, reduce requirement for opiate analgesia, prevent overuse of antibiotics and reduce substantial costs to the healthcare system.

This research project is being conducted to compare the Pharmacokinetics and Safety of The Potential Biosimilar Neulara with Ustekinumab in Healthy Volunteers