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Despite the many treatment options available for clinically depressed patients, there is a need for more effective treatments, particularly for TRD and specifically for therapeutic options that lead to more rapid symptom resolution. This is a multi-centre, Phase 2a study, which incorporates a 1-week enrichment open-label phase followed by randomised, double-blind, placebo-controlled phase, to investigate R-107 (30mg, 60mg, 120mg or 180mg) versus placebo in TRD subjects who respond to the 1-week enrichment open-label phase. Each subject will participate in up to 4 phases: • Phase 1: A screening phase of up to 3 weeks (Day -21 to -1); • Phase 2: An enrichment phase: open-label treatment phase for 1 week (to identify responders for the enrichment population in the subsequent double-blind treatment phase); • Phase 3: A double-blind treatment phase for 12 weeks (Day 8-92); • Phase 4: A 4-week post-treatment (follow-up) phase.

This clinical research study is comparing two techniques of radiofrequency neurotomy (RFN) treatment for chronic lower back pain that originates from facet joints. Patients taking part in this research study will therfore have chronic low back pain originating from facet joints. In addition, to take part in this study, the patients will have previously benefited from an RFN procedure and agreed to undergo another RFN procedure.

This project will assess a novel adjunct, the OxyFriend- a moulded silicon apparatus which sits on the patient’s face. The OxyFriend allows passage of nasal cannula with an anaesthetic mask placed over it. The device seals around the nasal cannula and may reduce leak. The project will primarily assess whether use of the OxyFriend can improve speed and efficacy of pre-oxygenation compared to conventional treatment and whether the OxyFriend device can reduce leakage of the anaesthetic mask.

Spontaneous bacterial peritonitis or in short ‘SBP’ is a life threatening bacterial infection within the excessive abdominal fluid that accumulates in patients with advanced liver cirrhosis. SBP if discovered or treated late can cause prolonged hospitalisation and even death. The key to treatment of SBP is early detection or prophylactic antibiotic use to prevent its occurrence. It is well known that prophylactic antibiotic use can prevent SBP occurrence but can be associated with side effects of the antibiotics and development of multi-resistant bacteria. Current research to date has limited information on which patients may best benefit from prophylactic antibiotics and there is lack of consensus between experts in this field. The theory behind development of SBP is through the concept called bacterial translocation. The passage of pathogenic bacteria from the inside of the gut through the bowel wall barrier into the gut tissue leads to eventual infective process. One of the key changes that contribute to development of SBP in context of advanced liver cirrhosis is the change that occurs in the gut barrier. Patients with liver cirrhosis have increased permeability or ‘leakiness’ of the gut barrier, thereby allowing pathogenic bacteria to leak across the barrier into the tissue space. This is often compounded by the abnormal overgrowth of pathogenic gut flora in patients with liver cirrhosis. We propose that by determining which patients with liver cirrhosis have highly abnormal gut permeability will allow us to predict who will best benefit from prophylactic antibiotics. We hypothesize that individuals with high gut permeability are most at risk of SBP and would have the most benefit of prophylactic antibiotic use. There has been long standing safe method of measuring gut permeability in children with many different gut disorders since 1980 by measuring two different types of ingested sugars, namely rhmanose and lactulose on a blood or urine test. The test allows measurement of the ingested sugars which crosses the gut barrier into the blood or urine at a set time to determine the functionality of the barrier. The study aims to recruit patients with advanced liver cirrhosis and examine their gut permeability by using this dual sugar test. Subsequently patients with abnormal permeability will be randomised to antibiotics or no antibiotic prophylaxis in a controlled trial to observe its benefit.

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics of ascending multiple doses of XW10172 compared to placebo.

This will be a two part, single-center, randomized, crossover study to investigate the impact of ritonavir co-administration on PRN1008 pharmacokinetics, and to assess the effect of therapeutic and supratherapeutic concentrations of PRN1008 on the QT interval. Participants may enroll in Part A or Part B; participants may not enroll in both Parts. Participants will be screened for this study within 28 day before dosing. Total length of participation in the study for study participants is; Part A, 46 days and Part B 53 days, from study screening through study completion.

Background. Chronic lung allograft dysfunction (CLAD), and especially bronchiolitis obliterans syndrome (BOS), remain dominant causes of morbidity and mortality after lung transplantation. Interest is growing in the forced oscillation technique, of which impulse oscillometry (IOS) is a form, as a tool to improve our understanding of these disorders. However, data remain limited and no longitudinal studies have been published, meaning there is no information regarding any capacity IOS may have for the early detection of CLAD. Methods. We conducted a prospective longitudinal study enrolling a consecutive sample of adult bilateral lung transplant recipients with healthy lung allografts or CLAD and performed ongoing paired IOS and spirometry tests on a clinically determined basis. We assessed for correlations between IOS and spirometry and examined any predictive value either modality may hold for the early detection of BOS. Results. We enrolled 91 patients and conducted testing for 43 mo, collecting 558 analyzable paired IOS and spirometry tests, with a median of 9 tests per subject (interquartile range, 5–12) and a median testing interval of 92 d (interquartile range, 62–161). Statistically significant moderate-to-strong correlations were demonstrated between all IOS parameters and spirometry, except resistance at 20 Hz, which is a proximal airway measure. No predictive value for the early detection of BOS was found for IOS or spirometry. Conclusions. This study presents the first longitudinal data from IOS after lung transplantation and adds considerably to the growing literature, showing unequivocal correlations with spirometry but failing to demonstrate a predictive value for BOS.

CNSA-001 represents the first viable formulation of sepiapterin intended for the treatment of hyperphenylalaninemia (HPA) in PKU patients. This Phase 2 study will assess 2 doses of CNSA-001 in comparison to the maximum recommended dose of Kuvan. This is a proof-of-concept (PoC) study that will help to establish dose selection and support the design of future Phase 2/3 studies in PKU patients.

Children with ASD aged 3 - 5 years old will receive a twice-daily nasally-administered oxytocin or placebo nasal spray for a period of 12-weeks and will also concurrently receive 16 sessions of the Parent-Delivered Early Start Denver Model early learning intervention. Assignment to either the placebo or oxytocin group will be randomised with researchers and participants unaware of treatment group allocation (blinded). Using this double-blinded placebo-controlled between subjects design we hope to identify children with ASD who may benefit from this treatment and the associated cognitive/neurobiological markers that predict these benefits. It is hypothesised that at post-treatment and at three-month follow up, OT treatment combined with P-ESDM will: 1. Improve caregiver-rated social responsiveness as measured by the Pervasive Developmental Disorder Behavior Inventory – Screening Version (PDDBI-SV)

Hypertension does not discriminate; it can affect anyone regardless of age, gender or fitness status. 6 Million Australians (34%) suffer from high blood pressure. Of these, 68% have uncontrolled or unmanaged high blood pressure. This means 4 million Australians are at a greatly increased risk of heart attack or stroke. Out of the 2 million people that are managed, 1 in 3 people measure blood pressure incorrectly at home with current BP monitors. 1 in 3 people have difficulty applying a conventional BP cuff. Tournicare Pty Ltd is developing a BP monitor, Tournicare, that promotes correct placement using only 1 hand. This trial aims to test the safety, accuracy and ease of use of Tournicare compared to a clinically validated home BP monitor. Tournicare will be tested on up to 30 generally healthy participants. Each participant will have their blood pressure measured multiple times over a 15 minute period. The participant will perform successive BP measurements followed coinciding measurements performed by a registered nurse with Tournicare on the left arm and the standard BP monitor on the right arm. The monitors will then switch arms and coinciding measurements will be repeated. During the process the participants will be asked questions regarding usability and user experience.