ANZCTR search results

This study is designed to develop an accurate digital diagnostic test, used on a smart device, to measure the severity of asthma. These tests can then be used in resource-poor communities, emergency departments or via telehealth applications. The test would improve asthma action plans, a mainstay of asthma management. The aim is to develop tests that are as accurate as an expert clinical assessment but do not need a clinical examination or other interventions such as bronchodilator (Ventolin) tests.

Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria causing infections in humans. While the overall numbers affected is small, the prevalence of infections is increasing. Individuals with cystic fibrosis (CF) and bronchiectasis are at particular risk of MABS becoming established within their lungs, resulting in a clinical spectrum ranging from simple colonisation to severe infection with increased healthcare utilisation and mortality. There is no evidence for either the timing of starting therapy, or for the currently used treatment regimens, which are complex, often poorly tolerated, and involve multiple expensive and toxic drug combinations given for at least 1-2 years. These considerable challenges have resulted in very few clinical trials being performed leaving an urgent clinical management evidence vacuum. Population: Those with MABS positive respiratory samples. Intervention: We aim to build an iterative, experimental clinical trial platform with adaptive properties and an observation arm to enable multiple treatment combinations to be evaluated in patients with and without CF, in those infected with different MABS subspecies, and strains with macrolide resistance. The platform will enable future novel treatments to efficiently enter the trial as they become available. Comparison: The trial platform will include the current standard of care as a comparator arm; as evidence is accumulated new comparators may be incorporated. Outcome: The trial platform will facilitate the evolution of optimal management for MABS lung disease with primary outcome of microbial clearance and include pharmacokinetic and health economic evaluation. Biomarkers will be developed to guide when to initiate treatment, and enable the monitoring of treatment responses. This will reduce unnecessary treatment associated toxicity and costs and enable targeted therapeutic approaches to maximise clinical benefit.

Background: clozapine is the most effect antipsychotic drug for treatment-refractory schizophrenia. Approximately 3.8% of people prescribed clozapine develop neutropenia which necessitates discontinuation of drug. Cessation of clozapine often results in psychotic rebound symptoms and may deny highly disabled patients the only effective means of psychotic symptom control. Despite this clozapine rechallenge is rarely undertaken due to concerns about the morbidity of recurrent neutropenia and lack of evidence based rechallenge strategies. One option for clozapine rechallenge is the concomitant use of prophylactic granulocyte-colony stimulating factor (G-CSF) to prevent recurrent neutropenia. However, there is limited current literature reporting the safety and efficacy of such an approach. A recent review identified 23 cases of clozapine rechallenge using prophylactic G-CSF in people previously experiencing clozapine associated neutropenia. This review reported a success rate of 70% at follow-up of one year with a favourable safety profile. However, the protocol for rechallenge was not standardised across cases, analysis was retrospective in most cases and there was risk of reporting bias given most data were derived from case series or single case reports. Further prospective evaluation of prophylactic G-CSF use for clozapine rechallenge in people previously experiencing clozapine associated neutropenia would be beneficial to determine the safety and efficacy of such an approach. Principals and rationale of therapeutic strategy: G-CSF has an established evidence base for the prevention of chemotherapy induced neutropenia and is also effective at augmenting neutrophil counts in people with congenital neutropenic syndromes and immunologically mediated neutropenia. Furthermore, G-CSF is beneficial in reducing the duration of clozapine-associated neutropenia following drug cessation. In people previously experiencing clozapine-associated neutropenia who are re-exposed to clozapine, G-CSF could plausibly augment neutrophil counts to prevent recurrent neutropenia. Hypothesis: use of regular G-CSF can be used safely in people previously experiencing clozapine-associated neutropenia during re-initiation of clozapine to prevent recurrent neutropenia and facilitate ongoing use of clozapine.

An ICU stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, usually delivered to ICU patients as liquid feed via a tube into the stomach. The provision of additional protein has the potential to improve at least part of the significant muscle atrophy that occurs, and hence enhance functional recovery from critical illness. A number of observational research studies have reported that a large proportion of ICU patients do not meet prescribed protein targets, with protein delivered closer to prescribed targets associated with reduced mortality, ventilation and ICU and hospital length of stay. Currently guidelines recommend delivery of protein doses of 1.2 - 2.0 g/kg/day or higher, but this is based on very low quality of evidence. Therefore, there is a need for high-quality randomised controlled trials of differing protein doses.

Despite the seriousness and the often poor prognosis of eating disorders, little research has evaluated nutrition and dietetic treatment options. Specifically, no randomised controlled trials have been conducted exploring the impact of dietitian-delivered evidence based nutrition and dietetic treatment for eating disorder patients either alone or as part of a multidisciplinary treatment team. This study aims to evaluate the effectiveness of providing five sessions of tailored nutrition and dietetic intervention on the outcomes of patients aged 16 years or older who are also receiving psychological intervention for an eating disorder. Qualitative research methods will also be utilised to explore participants’ satisfaction and acceptability of the nutrition and dietetic intervention they receive as well as the involved clinical psychologists’ satisfaction of working with a dietitian to provide treatment for patients with an ED.

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. These groups include Topotecan and Cyclophosphamide (TC), Carbonplatin and Etoposide (CE) and high dose Ifosfamide (IFOS). 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.