ANZCTR search results

The primary purpose of this study is to determine whether omega-3 fatty acid dietary supplementation will reduce blood biomarkers of inflammation and improve blood vessel function in patients with a small abdominal aortic aneurysm. We hypothesize that 12 week dietary supplementation with omega-3 fatty acids will reduce the concentration of inflammatory biomarkers in the blood, and improve indices of arterial stiffness. We will recruit 50 patients who have small abdominal aortic aneurysm (maximal diameter of 3.0-4.9 cm, determined by non-invasive imaging techniques). Participants will visit the laboratory for testing on 4 separate occasions (Day 0 and Weeks 3, 8, and 12). Blood and urine collections, and testing of vascular function will carried out during the Day 0, Week 3 and Week 12 visits. Participants will be randomized to receive fatty acid capsules (active or placebo), and will take 3/day for 12 weeks. Participants and investigators will be blinded to the treatment groups. Unused capsules will be returned by the participant at their next visit. The research team include vascular surgeons and fundamental scientists.

This study aims to examine the safety and effect of 12 months of BGP-15 treatment on heart function in people with non-ischemic dilated cardiomyopathy. This is a phase 2, randomised, double-blind, placebo-controlled, adaptive design study of orally administered BGP-15 in patients with evidence of increased cardiac fibrosis as suggested by cardiac MR imaging. Safety monitoring will be conducted at 3, 6 and 12 months of drug therapy. Efficacy will be assessed by cardiac MR, echocardiography and exercise capacity tests at baseline, 6 months and 12 months. The adaptive design study has 2 parts. Part A involves treatment of 30 participants with placebo and 2 doses of BGP-15. Safety analysis by an independent DMC will recommend an on-going dose for Part B (or termination if required). Part B involves 60 patients treated with placebo and one dose of BGP-15.

Patients who require treatment in the Intensive Care Unit (ICU) can develop stomach ulcers or duodenal (small intestine) ulcers. This occurs most commonly when life support (a breathing machine) is required or when the patient develops a bleeding tendency as a result of their illness. These kinds of ulcers are known as ‘stress ulcers’ and may cause life-threatening bleeding. Patients who require life support in the ICU are typically given one of two types of medicine to try and prevent the development of stress ulcers. The two types of medicines are called ‘proton pump inhibitors’ (PPIs) and ‘histamine-2 receptor blockers’ (H2RBs). While the prevention of stress ulcers is very important, the medicines used to prevent ulcers may have important side effects including an increased risk of developing certain kinds of infections. The risk of side effects may depend on the medication used. This study will establish which of the two types of medicines that are commonly used for stress ulcer prophylaxis in ICU patients who require life support leads to the lowest risk of upper gastrointestinal bleeding, prolonged mechanical ventilation, and Clostridium difficile infection. The study will use a design known as a ‘cluster crossover registry design’. In this type of study, data are collected primarily from existing data sources rather than the medical records of individual patients. There will be two study treatment periods. During the first treatment period, half of the participating ICUs will be randomly (like the toss of a coin) instructed to use PPIs for stress ulcer prophylaxis in patients who require life-support while the other half will use H2RBs. During the second treatment period each ICU will swap to using the opposite treatment. This means that, in situations where PPIs and H2RBs are regarded as being equivalent by the treating clinician, the treatment administered to the patients will be determined based on the treatment assigned to the patient’s ICU. However, if there is a specific indication for either PPI treatment or H2RB treatment (for example, an allergy), the treatment indicated for the particular patient concerned will be administered irrespective of the treatment assigned to the ICU.

This study is the first large-scale trial of Functional Imagery Training (FIT). FIT aims to enhance the effectiveness of existing best treatment for alcohol use, Motivational lnterviewing (MI), by harnessing the motivational power of mental imagery. Alcohol misuse is a high prevalence problem with substantial health and social impacts. This study examines the additive effect of embedding FIT techniques within MI when treating Alcohol Use Disorder. A total of 480 participants who are drinking >4 standard drinks per day on average and who meet criteria for DSM-5 Alcohol Use Disorder will be recruited and randomly allocated to one of the following three treatment groups: 1. Motivational Interviewing (MI) – delivered by phone in 2 calls over 1 week. Treatment contact time totals 2 hours. Participants discuss the advantages and feasibility of reducing drinking, and therapists elicit emotional reactions and dissonance between core values and current behaviour. 2. Motivational Interviewing plus Support (MI+S) – delivered by phone in 8 calls over 25 weeks. Treatment contact time totals 3.5 hours. MI+S has the same initial sessions as MI. Later calls offer non-specific support and social reinforcement for progress and encourage brief relaxation practice, but do not shape new coping strategies unless a lapse occurs. A smartphone app assists practice of progressive muscular relaxation, including an audio file to guide practice and photos of peaceful nature scenes. 3. Functional Imagery Training (FIT) – delivered by phone in 8 calls over 25 weeks. Treatment contact time totals 3.5 hours. Is based on MI+S but uses imagery throughout the sessions. During sessions, participants generate multisensory images about positive outcomes from controlling drinking, past success with self-control, and strategies to control drinking. Later sessions elicit achievements, outcomes and effective strategies, rehearsing imagery and making it routine by linking it to daily tasks. Mindfulness is practised instead of relaxation. A smartphone app assists practice of imagery, including an audio file to guide practice and the ability to take photos to facilitate practice. Participants complete assessments at Baseline and at 3, 6, and 12 months post-Baseline. Follow-up assessors are blind to treatment condition.

Background Although i.v. lidocaine is used as a perioperative analgesic in abdominal surgery, evidence of efficacy in terms of surgical recovery, pain scores, and opioid use is limited. The infusion dose and duration remain unclear. This study aimed to investigate the effect of a longer low-dose 48-hour infusion regimen on these outcomes. Methods Fifty-eight adult patients undergoing elective open colorectal surgery were randomised into the lidocaine group (1.5 mg kg-1 followed by 1 mg kg-1 h-1 infusion for 48 hours) and control group (administered equal volumes of normal saline). After surgery, patients were given a patient-controlled analgesia (PCA) machine and time to first bowel movement (primary outcome) and flatus were recorded. Postoperative pain scores (numeric rating scale) and fentanyl PCA consumption were assessed for 72 post-operative hours. Results There was no significant difference in time to first bowel movement [80.1 (42.2) vs 82.5 (40.4) hours; (P=0.83)], time to first flatus [64.7 (38.5) vs 70.0 (31.2) hours; P=0.57], length of hospital stay [9 (8–13) vs 11 (9–14) days; P=0.53], nor post-operative pain scores in the lidocaine vs control arms. Cumulative opioid consumption was significantly lower in the lidocaine vs the control group from 24 hours onwards. At 72 hours, cumulative opioid consumption (mcg fentanyl) in the lidocaine group [1570 (825-3587)] was over 40% lower than in the placebo group [2730 (1778-5327); P=0.039]. Conclusion A 48-hour low-dose i.v. lidocaine infusion reduces postoperative opioid consumption. This is not associated with faster return of bowel function, hospital discharge, or lower pain scores.

A quasi-experimental repeat cross section study design to determine the effectiveness of the childhood obesity prevention program called OPAL (Obesity Prevention and Lifestyle) run in 20 communities across South Australia.

Bone responds to mechanical stimuli, with the greatest response from high loads being applied quickly. High loads have remain unexamined in postemenopausal women with low bone mass due to the perceived risk of injury. The LIFTMOR trial was developed to see if the loads required to obtain the a greater bone response are both safe and effective in postmenopausal women with low to very low bone mass.

Post-natal depression affects a mother's wellbeing and also has developmental and emotional risks for her child. More research is urgently required on interventions employing combined treatment for post-natal depression and the parenting relationship. This study trials an adapted interpersonal psychotherapy (IPT) for post-natal depression which incorporates a focus on the mother-child relationship and uses attachment theory to inform that focus where required. The study is a controlled trial with cluster-allocation of participants identified by their maternal and child health nurse as being at risk. Participants who meet criteria for post-natal depression will be allocation in groups of between three and five to either a group therapy of a 10-week IPT with mother-child content (IPT-MC), or to treatment as usual via their maternal and child health nurse. The trial addresses the need for investigations into combined mother-child relational and mood interventions. It recognises difficulties associated with the recruitment of new mothers suffering from depression and attempts strategies to overcome these barriers to care.

The aim of the study is to examine whether D-Cycloserine can augment graded exposure therapy for children and adolescents with Obsessive Compulsive Disorder. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NMDA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia, or fear of heights and OCD in adult samples. The drug has recently been used to augment exposure therapy for children and adolescents with OCD.

This is a second in human study for DMTS. This open-label study consists of 2 parts: Part 1 is a single ascending dose study to determine the maximum tolerated dose of DMTS. Part 2 is bioavailability study The primary objective of this study is to determine the maximum tolerable dose (MTD) of the DMTS following a single 3 -day application (Part 1) and how much dexmedetomdine from the DMTS at the MTD is available in the body after a 3-day treatment (Part 2).