ANZCTR search results

The purpose of this study is to test the safety of the drug Eurartesim (trademarked). The drug is to be used for the treatment of uncomplicated Plasmodium Falciparum (a type of malaria, a mosquito borne infectious disease). A number of safety studies have been completed for this new drug, but the company requires more information about what happens when taking this drug in certain groups of people, including the differences between men and women, and the differences between asian and caucasian (western) people and the difference in body weights ( particularly people weighing less than 65 kg and those weighing more than 65kg). The study is to be conducted in helathy people to comapre how the drug behaves in these groups.

Children with type 1 diabetes have detectable arterial endothelial dysfunction and arterial intima-media thickening as first markers of accelerated atherosclerosis. They can be reliably measured to test the effectiveness of early intervention strategies. Folic acid supplementation significantly reduces the risk of stroke in adults, with most benefit in primary prevention. We have demonstrated that folic acid supplementation 5 mg daily rapidly normalizes endothelial function in children with type 1 diabetes, independent of homocysteine lowering. However there are no dose response studies of the benefit of folic acid to determine the minimum effective dose. This is relevant as while high dose folic acid does not have short term adverse effects, recent epidemiological data questions its long term safety in individuals with established vascular or early neoplastic disease. Determining the minimum dose of folic acid that improves endothelial function and the effect of endothelial nitric oxide synthase polymorphisms on the response to folic acid, will also inform future intervention trials for accelerated atherosclerosis in this age group.

This study looks at the effectiveness and tolerability of integrated radiotherapy and chemotherapy with oxaliplatin 5-flurouracil (5-fu) and folinic acid before surgery in patients with locally advanced adenocarcinoma of the rectum (back passage). Who is it for? You can join this study if you have locally advanced cancer of the rectum (back passage) which you have not yet received treatment for. Trial details Participants will receive integrated preoperative radiotherapy with FOLFOX chemotherapy over 11 weeks, prior to standard surgery 4-6 weeks later . Patients will be monitored to determine their tolerance and response to treatment.

To study the effects of Low GI diets in pregnancy. We wish to examine the effect of a low Gi diet on birth weight, development of gestational diabetes and child obesity.

This randomised, placebo-controlled and blinded study aims to quantify the effect of regular oral gabapentin (28 day course) on the incidence and severity of pruritus in children with acute severe burns. Itch will be assessed using standardised age appropriate itch scales. The primary outcome measure will be the proportion of children who are itch free in the final week of a four week study period. Secondary outcomes will include the average severity of itch during the four week study period and the use of conventional rescue anti-pruritic medication. Other secondary outcomes include parental satisfaction and reported pruritus severity at 3months after discharge (obtained through a follow-up phone interview). Although not the primary focus of this study, the effect of gabapentin on pain scores and opioid requirements in these patients will be explored. The is a single-centre, investigator-driven study that will be conducted within the Burns Unit at the Children’s Hospital at Westmead, which is the referral centre for all children with burns in New South Wales. Modest financial support for this study has been obtained from the Society of Paediatric Anaesthetists of New Zealand and Australia.

The aim of this follow-on study is to determine if transcutaneous pulsed radiofrequency treatment (PRFT) can reduce shoulder pain and if multiple treatments are better than one. Shoulder pain is third most common musculoskeletal problem in the general population and accounts for 5% of general practitioner musculoskeletal consults. The incidence of shoulder pain is 6.6 to 25 cases per 1000 patients, with a peak incidence in the fourth through sixth decades. Favourable outcomes have been reported from case series of transcutaneous PRFT described in conference proceedings and the literature. Our earlier double blind “active” versus “sham” study of 2 Hz 20ms 80V transcutaneous PRFT(ACTRN12609000146291) reduced knee pain by 30% at 1 month. Transcutaneous PRFT is a painless, non-invasive, non-destructive, needle-free treatment that applies a pulsing electrical field around the target nerve using surface mounted electrodes to ‘stun’ rather than destroy the nerves, rendering the nerve incapable of transmitting pain signals. It is not known how transcutaneous PRFT works, however, it is thought to induce long lasting biochemical changes in the target spinal nerves without disrupting sensation or motor function. Treatment can be repeated if there is a good response to the first transcutaneous PRFT. 50 patients referred to Frankston Hospital for non-stabilisation surgery for shoulder pain will be invited to participate in a double blind randomised placebo controlled (DBRPC) trial of transcutaneous PRFT. Patients with an unstable shoulder or unable to communicate in English or don’t want to participate will be excluded. The outcome will be determined by comparing pre and post transcutaneous PRFT self-report of pain intensity, global satisfaction, medication use and Oxford Shoulder Score questionnaire.

Evidence suggests that young people with Type 1 diabetes (T1D) are vulnerable to a range of mental health difficulties, including depression and anxiety. Furthermore this vulnerability can be heightened when these young people are isolated from support services, such as is the case for those living in rural areas or experiencing social isolation. The study aims to assist adolescents with T1D and their parents to manage the psychosocial impact of their condition, improve their mental and physical health outcomes, and reduce their risk taking behaviour. The study has two phases. Phase 1 is an interview study of parents (n=10) of adolescents with T1D who are prepared to discuss their experiences of parenting a child with diabetes in relation to their preferences and needs for treatment and internet based interventions. Findings from the parent interviews and an earlier needs analysis study of rural adolescents with T1D and their parents, conducted by the researchers, will be used to revise and supplement the prototype NV-NG adolescent intervention with a parenting intervention. The parent component will be based on an existing parenting program and associated web-resources and will result in an integrated adolescent and parenting program, which will be evaluated in Phase 2 (the Evaluation Phase). The evaluation phase will comprise a randomised control trial (with a wait group control) to evaluate the effectiveness of the NVNG program with a sample of approximately 120 (60 intervention, 60 wait group) adolescents aged 13-18 and one of their parents (n=120, 60 intervention, 60 wait group control). Adolescent/parent dyads will be recruited by a rolling recruitment strategy through The Royal Children’s Hospital Diabetes Outreach Clinics and Monash Medical Centre, in Victoria. Pre-Post intervention/wait measures will be administered via online questionnaires at baseline (t=0), on completion of the program (t=6weeks); and 6 months after completion of intervention/wait. Online questionnaires completed by adolescents and their parents will assess a range of psychosocial factors including: negative emotions (e.g. depression, anxiety), quality of life, diabetes self efficacy, resilience, availability of social support, risk taking behaviours, diabetes self care, and perception of parent/adolescent conflict. Parent questionnaires will assess negative emotions, self efficacy, parent perception of child well being, and family conflict. In addition the adolescents’’ glycylated haemoglobin (HbA1c) results at pre-intervention and follow-up will be used as an objective measure of diabetes control. We aim to establish the extent to which positive outcomes are achieved for both adolescents and their parents.

The study found a significant difference in the median CYP1A2 activity in those of South Asian and European ancestry.

The primary purpose of the study is to assess whether this herbal preparation can manage and improve the symptoms associated with BPH such as increased frequency of urination, difficulties with starting stopping urination and difficulties in postponing urination.

Very preterm infants are particularly susceptible to ventilator induced lung injury and methods of non-invasive respiratory support, the commonest being CPAP are known to reduce the risk of lung injury. However, the optimal pressure levels remain to be determined. Will very preterm infants with respiratory distress syndrome who are being extubated to CPAP initially need higher CPAP pressures than are usually used in order to restore and maintain lung volume? Our hypothesis is that infants extubated to nasal CPAP will initially need higher CPAP pressures than the mean airway pressure delivered by the ventilator prior to extubation in order to restore and maintain lung volume