ANZCTR search results

This study aims to test the efficacy of a decision-making tool, called a Decision Aid, for women with epilepsy who are in the process of deciding whether or not to have a child. It is hypothesised that women with epilepsy who receive the Decision Aid will report increased knowledge about pregnancy; reduced decisional conflict and increased decisional self-efficacy regarding their decision compared to women who do not receive the Decision Aid. In accordance with previous research, the Decision Aid is not expected to affect depression, anxiety or the direction of a woman's decision.

Malnutrition is a condition with negative implications affecting a substantial number of patients in healthcare facilities across Australia. It develops as a result of inadequate food intake, occurring due to factors associated with disease, illness and ageing and is often exacerbated by aspects of the hospital environment such as food provision. Preliminary data collected from subacute care inpatients (rehabilitation and Geriatric Evaluation and Management (GEM)) underpins this intervention trial. This research found that the 30% of patients were malnourished on admission and that overall, patients lost weight and muscle mass, demonstrating a decline in their nutritional status during inpatient stay. Additionally, less than 15% of patients consumed sufficient food or drink to provide 100% of their energy requirements and only half of all patients met 75% of their requirements. Well-nourished and malnourished patients alike experienced inadequate intake and nutritional decline. These data strongly suggest the need for more effective interventions to lower the risk of progression of malnutrition in healthcare facilities. Modifying or enhancing the nutritional value of food or drink or increasing the provision of items at meals and mid meals in hospital may be an approach that is more palatable and satisfying for patients and economically beneficial, compared to the provision of oral nutrition supplement drinks which are used widely in practice. There is some evidence from a handful of studies conducted across a range of healthcare settings that food based approaches result in greater dietary intake and patient centred outcomes, but there is a lack of evidence on clinical and functional benefits and cost. Additionally, previously high quality studies are lacking. The aim of this research is to implement a novel food service model to determine the effect of a nourishing menu compared to a usual menu on nutritional and clinical outcomes, patient satisfaction and cost among malnourished and well-nourished adult sub-acute care patients. This research will test the null hypotheses that there is no difference in weight change and cost of delivery between the intervention and the control. It is anticipated that the findings of this research, including data on cost of food service interventions, will have clinical relevance for the operation of the food service systems and dietetic practice.

To characterize the pharmacokinetics (PK) of three IPX233 formulations (C0001, C0002, T0001) compared with one IPX233 formulation (T0002).

This project will examine the effect of weight loss induced by the administration of the GLP-1 analogue, liraglutide, in combination with bariatric surgery or medical management on factors associated with metabolic and end-organ abnormalities. It is likely that liraglutide will improve the metabolic and neurohormonal profile of patients with obesity. Complications of obesity including cardiac pathology, neurocognitive dysfunction and sleep-disordered breathing may improve as a result of weight loss, with the use of a GLP-1 analogue.

Complications of ear disease, including hearing impairment and chronically infected ears, particularly chronic suppurative otitis media, can affect education, social circumstances and quality of life. Aboriginal and Torres Strait Islander children are known to have higher rates of otitis media than other children and to be more likely to develop complications. However, almost all of the research into prevalence, risk factors and treatment has been done in remote settings, despite the majority of Aboriginal and Torres Strait Islander peoples living in urban areas. In developed countries, immediate antibiotic treatment confers only a modestly decreased duration of pain and fever. Given the public health risks of antibiotic resistance, a “watchful waiting” approach to treatment is recommended for children at low risk of complications of AOM. Similarly, a recent change in national guidelines for treatment of AOM in Aboriginal and Torres Strait Islander children has recommended a shift from giving immediate antibiotic therapy for all such children, to using a “watchful waiting” approach in urban children presumed to be at low risk of complications. We will work with five Aboriginal Community Controlled Health Services and one Indigenous health service. With these services we will recruit approximately 500 children in order to provide randomised controlled trial (RCT) evidence to determine if watchful waiting is at least as effective as immediate antibiotic treatment for urban Aboriginal and Torres Strait Islander children with AOM. In addition, we will examine the cost effectiveness of the two treatment approaches from health services, societal and individual patient perspectives. We will also undertake qualitative research including process evaluation to document the implementation of the trial in each site, and the views and attitudes of the health care providers and study participants to the study and to the conduct of an RCT in Aboriginal and Torres Strait Islander communities. This is the first trial of antibiotics versus watchful waiting in urban Aboriginal and/or Torres Strait Islander children who present to a primary health care service with AOM. This research addresses two NHMRC priorities: Aboriginal health; and hearing. Our investigator team includes two Aboriginal researchers and staff from three Aboriginal health services who have contributed to this proposal from its early stages. Our research team is well placed to ensure translation of the research findings into policy and practice.

Colo-rectal cancer is increasing in the community and the most common site of spread is to the liver. Isolated liver deposits can be cured by surgery. For patients not fit or suitable for surgery other options need to be investigated. This clinical trial is investigating the use of stereotactic image guided radiotherapy for the treatment of colorectal liver metastases. Who is it for? This study will recruit participants that are aged 18 years or above and have up to 5 medically or surgically inoperable colorectal cancer liver metastases. Study details: All participants in this study will undergo stereotactic radiation therapy. This is a type of external radiation therapy that uses special equipment to more precisely deliver radiation to a tumour. Six radiotherapy sessions will be delivered over 2-3 weeks. Participants will be assessed for 3 years post treatment in order to evaluate treatment safety and disease response.

Breathing problems persisting into infancy and later life is an important complication of premature birth with lifelong consequences. Breathing problems often occur together with lung disease, but prematurity can also affect heart and blood vessel development, and weakness of the main breathing muscle (the diaphragm). We will find out how much the heart, lung and muscles each contribute to breathing problems, as well as identify factors such as infection, nutrition and treatments that influence these and other long-term outcomes of very preterm birth. This knowledge will help us to better predict, diagnose, treat and prevent adverse outcomes after preterm birth.

The study is evaluating the maximum tolerated dose (MTD) by understanding the safety profile during incremental dosage escalation. Who is it for? You may be eligible to join this study if you are aged over 18 years with any histologically confirmed relapsed or refractory advanced haematologic malignancies for which no effective standard therapies are available, and have progressed following at least one prior treatment regimen. As every blood cancer patient has a unique disease and treatment history, it is highly suggested that you discuss the trial with your haematologist or oncologist who can also contact Peter Mac to determine whether this trial may be suitable for you. Trial details Participants in this study will receive CX-5461, an RNA polymerase I inhibitor. CX-5461 will be administered by intravenous infusion over 1 hour on day 1 and day 8 every 28 days. Four dose levels are planned: 70 mg/m2, 100 mg/m2, 150 mg/m2 and 220 mg/m2 per dose. Patients will be assigned to a dose level in the order of study entry. Participants will be required to undergo various assessment tests including blood, imaging, laboratory and physical assessment tests.

The CONTINUUM-HF study aims to evaluate whether vessel dilator peptide VSDL has effects on renal function in participants with acute decompensated congestive heart failure. It shall also evaluate the tolerability and safety of VSDL over 7 day dosing, and assess the pharmacodynamics of VSDL in these participants. The study is a multi-centre, blinded, randomised, placebo-controlled, multi-dose study to be conducted in 8 sites in Australia targeting two target peak concentrations following 1-hour intravenous bolus and daily 12-hour subcutaneous infusions for up to 7 days. The target plasma VSDL concentrations of 5ng/ml and 20ng/ml are chosen to reflect well tolerated and efficacious concentrations in previous trials using this drug. Study subjects shall be reviewed post-IV infusion, at 72 hours, pre-discharge, and at 30 days. A 6 month followup contact will be made via phone call or email. Participants will be given a diary to record any adverse events, changes in medication and visits to doctors.

Building emotional health in childhood sets the platform for a healthy and productive life. Optimising treatment outcome for common emotional disorders (e.g., anxiety disorders) in childhood is an important area of research. Research using anti-depressant medication in combination with CBT to treat anxiety has been conducted to investigate optimum treatment response. These studies indicate that combination therapy (CBT + anti-depressant medication) has greater efficacy than either treatment alone (March et al., 2004; POTS 2004). Such research provides the opportunity to use empirical data to inform treatment guidelines and enable child/adolescents and their families to receive the most efficacious interventions to reduce anxiety-related impairment and distress. However, research comparing the efficacy of interventions has typically employed a partially blinded approach, where participants are randomly allocated into Pill, Placebo, CBT only or Pill+CBT conditions. This research methodology is limited by the fact that participants receiving the combined CBT and pill treatment are aware that they are receiving two active interventions, so expectancy effects cannot be ruled out as a potential alternative explanation for the comparatively greater response rates found for participants in this condition (Hudson, 2009). Double-blinded research that compares the efficacy of CBT + placebo and CBT + pill conditions in the treatment of child/adolescent anxiety is necessary to clarify the additional benefits of combining medication with the currently recommended first line intervention, CBT. Additionally, existing research suggesting greater efficacy of combination treatment did not conduct long-term follow-ups. By adding long-term follow-ups the longer-term benefits of combination therapy for anxious children can be determined, and compared to the known long-term benefits of treating anxiety using CBT. It is expected that combined treatment (CBT + Sertraline) will produce better outcomes than CBT + Placebo condition for children and adolescents with anxiety disorders.