ANZCTR search results

The purpose of this study is to determine which of the most commonly used chemotherapy used in recurrent and primary refractory Ewing sarcoma is most beneficial. Who is it for? You may be eligible for this study if you are aged 2 years or above and have been diagnosed with relapsed or refractory Ewing sarcoma. Study details: Participants in this trial will be randomly allocated to one of the available treatment groups. Before treatment starts the following routine tests will be performed: Physical check-up including measuring height and weight Blood tests +/- urine tests Assessment of kidney function called a GFR. Scans (which may include CT, PET-CT, MRI, bone scan, x-ray). The doctor will decide which type of scans needed depending on where the tumour is located. A quality of life questionnaire will also be completed before treatment commences. During trial treatment While you are having chemotherapy treatment you will be carefully monitored using the same routine tests that would be used if you were having chemotherapy but were not in the trial. These routine tests will include blood +/- urine tests, scans and GFR. These tests are to ensure that you are fit to continue chemotherapy. In addition if you have had a PET-CT scan before treatment, you will have another PET-CT scan after 4 cycles of chemotherapy. You will be asked to complete two more quality of life questionnaires, one on completion of cycle 2 and one on completion of cycle 4. All treatments in this study are those which are currently used routinely for treatment of Ewing sarcoma. It is hoped that this research will help to determine which of the treatments is most effective in improving overall survival, side effects, tumour shrinkage, quality of life and days spent in hospital.

A double-blind, placebo-controlled, single ascending dose (SAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers. Healthy male or female adults with no significant ocular abnormalities will be enrolled. The plan is to enroll 40 subjects, in five cohorts of eight subjects each; additional cohorts (eight subjects per cohort) may be enrolled if it is deemed appropriate by the sponsor to repeat a dose level or to study another dose level. Within each cohort, six subjects will be randomized to receive active drug and two subjects will receive placebo. Each subject will participate in only one dose level. Subjects will receive single ascending doses of 50, 100, 200, 400, and 25 mg LBS-008 administered as 25 or 200 mg capsules, or an equivalent number of placebo capsules. Each dose cohort will be separated into two groups; a sentinel group of two subjects (one active and one placebo) will be dosed at least 24 hours before the remaining six subjects (five active and one placebo). The MAD portion will start after the completion of Cohort 4 of SAD and will have up to 4 cohorts and up to a total of 32 subjects (8 subjects per cohort). The starting dose of LBS-008 will be 10 mg and the planned doses for subsequent cohorts are 25, 5 and 12 mg. The final doses are determined based on the outcome of SAD portion.

An exercise intervention will engage 40 children with Attention deficit hyperactivity disorder (ADHD) in 8-12 years of age. The intervention group children will participate in an 8-week cricket program whereas the wait list group will do so after the three-time measurements on symptoms and life style patterns regarding sleep, physical activity, and screen time. We hypothesise the physical activity of a cricket program will significantly improve the participating children’s symptom and life style when compared with the wait list group.

Non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) is being increasingly trialled for the treatment of neurological disorders such as stroke and epilepsy. Epilepsy is known to be associated with alteration in brain excitability. tDCS is a safe and painless neurophysiological method used to alter the excitability of the brain. Childhood epilepsy is refractory to medical management in 30% of children, and other options (e.g. surgery) are not appropriate in many. Newer techniques such as tDCS are being trialled and show promise as treatment options. There are, however, only a few studies involving small numbers that have been reported so far, and more trials with tDCS in epilepsy are needed. Our study plans to evaluate the use of tDCS in children with refractory epilepsy, to assess the types of seizures that will respond to tDCS, the stimulation protocols that produce optimal benefit, and to evaluate any other beneficial and adverse effects. This study uses clinical assessments, EEG and transcranial magnetic stimulation (TMS) to monitor the effects of tDCS. Parents will be required to maintain a seizure diary to help evaluate the effects of tDCS.

This study looks at the male age effect on the sperm parameters and the clinical pregnancy and live birth rates in an IVF cycle. We included heterozygous couples using autologous gametes in their first fresh IVF cycle. We only included patients who had single embryo transfer.

The purpose of this study is to examine the area around a neuroendocrine tumour using a scan called FMISO PET. Who is it for? You may be eligible for this study if you are aged 18 or over, and have a metastatic neuroendocrine tumour (NET). Study details All participants in this study will undergo one FMISO PET. The scan requires injection of a chemical called a tracer through a needle in the arm. The scan takes approximately 2 hours with the whole study visit on the day taking approximately 3 hours. It is hoped this research will help clinicians understand the biology of NET better, and help improve health outcomes in the long term as a result of this improved understanding.

Impaired health can increase the risk of workplace accidents and injuries, and impair quality of life. For those who do not receive regular medical check-ups, which is often difficult in industries such as transportation due to long and irregular work hours, medical conditions can remain unrecognised. Conditions with a prolonged lead time from the development of the condition to the time of diagnosis are potential targets for screening programs, aiming at early identification and management resulting in improved symptoms and reduced risk of complications including workplace accidents. Over 60% of fatalities in the Victorian transport industry are caused by traumatic injuries and another 30% are caused by cardiovascular disease (CVD). High rates of sleep disorders are also reported in transport workers, and have been associated with an increased risk of accidents. Furthermore, short sleep for even one night has been associated with an increase in crash risk. Given that accidents, CVD and sleep are key and inter-related concerns for transportation workers, the current project assessed the impact of introducing a health screening program in the transport industry. This program was designed to educate and screen for CVD risk factors and sleep disorders, and identify and refer high risk workers for medical intervention via referrals and follow-up advice. It was hypothesised the health screening program would reveal a high prevalence of CVD risk factors and sleep disorders in transportation workers, similar to that demonstrated in previous research in this industry. Furthermore, it was anticipated we would achieve a high level of participation in the screening program and compliance with medical follow-up of abnormal results. Finally, we hypothesised the education and screening program would be associated with a reduced rate of workplace injuries. Educational programs were conducted at participating transport companies and all drivers at these companies were invited to participate in the health screening which consisted of the following measures: the Epworth Sleepiness Scale; the Multivariable Apnea Prediction index; frequency of sleepiness and falling asleep whilst driving; sleep duration; occupational factors (driving and work hours, driving distance, shift type); motor vehicle accident (MVA) history; CVD risk factors (gender, smoking, family history, blood pressure, blood glucose); body mass index; and alcohol intake. Participants received personalised feedback and advice dependent on the results of the screening. The primary outcomes of the project focused on determining the relationship between sleepiness (hypersomnolence) and sleep duration on MVA risk, and the relationship between occupational demands and cardiovascular health. The success of the screening program was also investigated by examining transportation workers’ compliance with medical follow-up recommendations and changes in workplace injury rates.

A few medications were reported to be better absorbed into the systemic blood circulation after administration under the tongue. In this study, the absorption of atropine into the blood circulation was measured after atropine solution administration under the tongue solution and oral administration. The extent of absorption of atropine after 0.6mg and 1.2mg dose administration of under the tongue atropine was also measured.

Enteral nutrition (EN), delivered via a tube into the stomach, provided to critically ill patients is largely inadequate, resulting in muscle wasting and reduced physical function in the long-term. Numerous factors are known to influence nutrition delivery in the intensive care unit (ICU) such as interruptions for procedures, delayed initiation of feeding regimes, under or over prescription, and feed intolerance due to delayed gastric emptying. Further, recent evidence raises doubt as to the benefit of early vs delayed initiation of enteral nutrition and the delivery of calories to full prescribed target early in critical illness. Therefore, an exploration of whether there has been a change in nutrition delivery over time to reflect recommendations, and whether potential barriers to nutrition adequacy are as prevalent now as in the past, is required.

In the proposed study, the treating electrophysiologist will use a new and more focused method to help him/her in identifying the pathological potentials that are responsible for initiation and maintenance of AF. Despite many efforts globally, there has been a lack of ability to find and prove the best targets for ablation outside the pulmonary veins for AF, which is of particular interest in improving the success of ablation for persistent AF. There is recent evidence for the DEEP method in mapping for VT procedures. The proposed method is based on a mechanistic concept that regions that participate in the initiation of AF will demonstrate significant decremental properties prior to block and reentry, when stressed by a closely coupled premature beat. This method simply requires some additional pacing and mapping of the response to this during the routine post-ablation waiting period while patients are already undergoing AF ablation. In this study, mapping of DEEP will be performed to determine its feasibility in atrial tissue, and the presence of DEEP will be tested as a predictor of recurrence of AF during the follow-up period of 12 months. Areas of DEEP will also be compared in location and extent to abnormal voltage and complex signals seen on standard mapping (such as complex fractionated atrial electrograms and re-entrant areas). Fifteen participants will be recruited at each of 5 international centres for a total of 75 participants.