ANZCTR search results

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

The purpose of this study is to test a health system intervention in Aboriginal Community Controlled Health Services. Who is it for? You may be eligible for this study if you are aged 18 or over and have had at least three visits to an Aboriginal Community Controlled Health Service in last two years Study details As this is a systems-level intervention, participants will continue their usual practice attending participating ACCHSs. Each ACCHS will have a period of usual practice before introduction of a set of strategies. These strategies include targets, training for ACCHS staff, feedback and introduction of new health resources. As part of this study, health service data will be collected from medical records. It is hoped this research will improve the quality and of service delivery by Aboriginal Community Controlled Health Services and improve access to health services by Aboriginal Australians.

Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub-optimal, and the prognosis for many patients is poor. Estradiol has a positive role in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia, but it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Bazedoxifene, a third generation Selective Estrogen Receptor Modulator (SERM), appears to be safer with respect to long term use than older SERMs, has additional actions on the glucocorticoid receptor, and together this different pharmacology speculatively has greater potential than other SERMs to impact favorably on both psychosis symptoms and cognition in men and women with schizophrenia. This study will test 100 men to determine if bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia. We hypothesise that bazedoxifene will significantly reduce psychopathology and will significantly improve cognition.

The purpose of this pilot study is to determine if using the PROMs and PREMs questionnaires in real-time within an outpatient clinic for those with cancer will help to identify patient concerns for immediate discussion and management with their treating teams. Who is it for? You may be eligible for this study if you are aged 18 or over, have a diagnosis of cancer and attend a Monash Health medical oncology outpatient clinic. Study details All participants in this study will complete a variety of questionnaires about their cancer and treatment experience. There will be study questions relating to cancer symptoms, services for support and your overall quality of life. These questionnaires will be available to complete online up to 2 days prior to routine clinic visits. No additional visits are required for participation in this study. Participants will also be asked to complete a survey and/or contacted via telephone to evaluate the study at the end of the research period. It is hoped this research will improve patient oncology services and identify that these questionnaires are feasible, acceptable and useful for patients and doctors in real time.

This is a double-blind, randomised, clinical study with a 14-day treatment duration with 2 arms (with 2 active ingredient groups and 2 placebo groups). The aim of this study is to assess the effectiveness of PEA and curcumin on reducing joint pain in otherwise healthy adults aged 25-70 years, compared to a placebo. A placebo is a substance with no therapeutic effect, in this case maltodextrin. Participants will be asked to attend our clinic to complete their enrolment with a Trial Coordinator. During this visit, they will also complete an initial assessment including, letting the trial coordinator know about their joint pain and general health by completing questionnaires; height and weight measurements; and a blood test. At the conclusion of the visit, participants will be randomly allocated to either the PEA, curcumin or placebo treatment group. Once enrolled in the study, participants will be asked to complete 3 days of pain recording (once morning and once at night) online. Following the completion of the 3 days of pain recording, trial coordinators will confirm supplementation commencement. Capsules should be consumed as described on the label. Once supplementation has started, participants will be required to record their pain level every morning upon waking, and every night prior to going to bed for 2 weeks. At the completion of the 2 weeks, participants will be required to attend the clinic for a final appointment where they will complete identical assessments to the initial visit.

This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 2. Part 2 is an open label, 2-period cross-over, randomised, pilot food effect study to provide preliminary information on the effect of a high-fat meal on the pharmacokinetics of a single-dose oral administration of ZY-19489 to healthy male and female subjects aged between 18-55 years old. Part 2 will consist of a single cohort of 8 subjects. For safety, the cohort will be split into 2 groups of 4 subjects each (Cohorts 1A and 1B). Adverse events and concomitant medications will be followed throughout the study. The study will be overseen by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.