ANZCTR search results

The current study aims to significantly add to existing research regarding the effectiveness of Dialectical Behaviour Therapy (DBT) group-based programs and Experience Sampling Methodology (ESM) interventions with young people (18-24 years). Research has found DBT to be an effective treatment model for adolescents who have a variety of mental health concerns, have trouble coping with their emotions or engage in risk behaviours (e.g. self-harm). Further, smart phone applications (ESM) designed to capture snapshots of daily experience and emotion have been used in mental health settings and found to reduce emotional distress and suicidal thinking. The current study will evaluate both interventions to investigate whether there is an increase in participants’ positive coping behaviours, and whether they could be translated to other settings (e.g. health settings, gatekeeper organisations). Understanding the complex interaction between experiences, emotional vulnerabilities and risk factors, which influence poor coping behaviours such as self-harm, would greatly benefit clinical practice and further inform prevention and intervention policies.

The purpose of this feasibility study is to evaluate whether it is possible to accurately, rapidly, completely and confidently, categorized critically ill patients early in their ICU admission into eight unique and predefined categories for the purpose of follow up.

The primary purpose of this study is to determine whether a very low energy diet (VLED) can reduce weight and improve outcomes in obese patients undergoing surgery for rectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over with a BMI greater than or equal to 30 and have been diagnosed with adenocarcinoma of the rectum for which surgery has been prescribed. Study details Participants will be randomly allocated (by chance) to either the Optifast diet treatment, or the usual care treatment. Participants on the Optifast diet treatment will be restricted to 800 calories or less per day for 4 - 6 weeks before the surgery, using the Optifast diet products including nutritionally complete soup sand shakes. Participants in the usual care treatment group will receive care and advice prior to their surgery as normal. Patient outcomes will then be assessed at visits in the hospital stay at day three, then at day 14, four to six weeks, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after discharge. Further long-term follow-up will be conducted annually for an additional three (3) years after the 24 months follow up visit at which participants will undergo a blood sample and physical examination. It is hoped that the findings of this trial will increase understanding of the potential benefits of a VLED prior to surgery in obese patients with rectal cancers.

Probiotics are live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host. Probiotics have been proven to reduce necrotizing enterocolitis, a devastating and life threatening emergency in neonates. Over recent years, the role of probiotics in improving gut motility and function has emerged. Probiotics, especially specific strains could improve nutrition in neonates by improving tolerance of oral feeds. Intolerance or poor tolerance of feeds along with repeated infections are some of the factors contributing to malnutrition in these high risk infants. Prevention of nutrition related issues in newborns will improve their long term development as well as their growth. We propose to compare single strain probiotic as compared to multiple strain probiotic for their ability to improve oral feed tolerance in neonates. We will be administering either the single strain or multi strain probiotic after allotting the infant into either one or the other group and then examine the baby’s stool for presence of these good bacteria (contained in the probiotic). We will also be looking at the complex genetic structure of the bacteria in stool and study if probiotics could change the bad bacteria to good beneficial ones. We will enrol all newborns less than 28 weeks of gestation, after parental consent. The probiotic supplements will be administered to the baby after starting oral feeds and continued till the baby is near term (37 weeks of gestation). Since probiotics improve intestinal motility, we will be investigating whether multiple strain probiotic will improve it to a better extent as compared to single strain probiotic. We will administer a small amount of dye orally to the infant and observe its excretion into stools. The better the effect on gut motility, the faster will be the excretion and shorter will be the time to excrete the dye as well. In summary, this project will help us to conclude whether multiple strain probiotic will be more beneficial as compared to single strain for routine use in this high risk population.

TOPS will be a pragmatic comparative effectiveness randomised controlled trial with a parallel economic evaluation. It will combine three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence), pending funding approval, using an identical methodology. 1482 participants who have recently recovered from low back pain will be randomised to either a comprehensive exercise and education program conducted over 12 weeks, consisting of a single one-hour assessment session, 3 individual half-hour education sessions and 8 one-hour supervised group exercise sessions; or a minimal intervention consisting of the ‘Guide to Positively Managing Back Pain’ booklet and one 30 minute education and advice session. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of low back pain.

The primary purpose of the study is to investigate whether ceasing the use of antidote (NAC) in patients presenting early with paracetamol overdose in a low risk population is feasible and safe.

The study aims to determine the benefit of phone coaching by an exercise physiologist to improve adherence to a prescribed home exercise program in the bariatric population. Improved adherence should increase physical function and quality of life and provide evidence for the development of a standardized approach for weight management.

This will be a single center, four-period, open-label, complete crossover study to investigating the single dose pharmacokinetics of PRN1008 when administered as a liquid formulation compared to a tablet formulation under fasted conditions, the effect of a meal on the single dose pharmacokinetics of PRN1008 when administered as a tablet formulation and also, the effect of prior administration of a Proton Pump Inhibitor on the single dose pharmacokinetics of PRN1008 when administered as a tablet formulation. Participants will be screened for participation within 28 days before dosing. Participants will be admitted to the study unit the day before dosing (Day -1), then dosed in the mornings of Days 1, 3, 5 and 10, and will remain in the clinic up to Day 11, after collection of the final PK sample. Total participation will be approximately 47 days.

60 participants will be recruited to complete 12 weeks of either single-leg high intensity interval cycling or double-leg high intensity interval cycling. This study aims to determine the functional, psychosocial and physiological effects of cycle exercise training using either one or two legs. This will be a parallel randomised group design recruiting individuals 18-80 years of age with established coronary artery disease.

The primary purpose of this study is to determine the efficacy and safety of carfilzomib-thalidomide-dexamethasone (CarTD) therapy for newly diagnosed transplant-eligible multiple myeloma (NDMM) patients who did not respond adequately to initial bortezomib-based therapy. Who is it for? You may be eligible to join this study if you are aged over 18 years, have been diagnosed with symptomatic NDMM as per International Myeloma Working Group (IMWG) criteria, are eligible for high-dose melphalan conditioned autologous stem cell transplant (ASCT) and failed to achieve a minimum response or partial response on 2 or 4 cycles of prior bortezomib-based induction therapy respectively. Study details Enrolled participants will first undergo 4 x 4-week cycles of salvage CarTD therapy, followed by an additional 2 cycles if they do not achieve a stringent complete response. Participants will then receive melphalan-conditioned ASCT, followed by 2 cycles of consolidation CarTD therapy. Patients will be monitored for myeloma response and safety and tolerability of CarTD therapy using blood samples, and the assessment of toxicities (adverse event review) as well as for disease progression and survival information for up to 3 years following the completion of treatment. It is hoped that the findings of this trial will provide an evaluation of the efficacy and safety of CarTD salvage and consolidation therapy in multiple myeloma patients who do not respond to the standard care bortezomib-based therapy.