ANZCTR search results

Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation causing progressive airflow obstruction. Previous research has shown that both the microbiome (bacteria, fungi and viruses) and dietary habits have a strong influence on inflammation in other chronic inflammatory diseases such as inflammatory bowel disease and asthma. Furthermore, dietary fiber supplementation has been shown to reduce inflammation in asthma through the metabolism of fiber by the gut microbiome and increasing the production of short chain fatty acids (SCFAs), which are anti-inflammatory. The main objective of this study is to test dietary fiber supplementation as an intervention to reduce inflammation in COPD, through alteration of the gut and lung microbiome and increased SCFA production.

Following and ACL reconstruction, approximately one quarter of patients are not happy with the outcome and do not return to their previous level of activity. The most common cause of this persistent instability following the ACL reconstruction. The best available clinical test for anterolateral instability, is the pivot shift test. In some patients, even following an optimally performed ACL reconstruction, there may be some persistent instability, or anterolateral rotator instability (ALRI) as evidenced by a persistent pivot shift maneuver. This may be caused by damage to anterolateral extra-articular structures. Reconstruction of these anterolateral structures has been shown to be able to improve the stability of the knee, and outcome following revision ACL reconstruction. Dr. Mark Porter, has already demonstrated that the addition of the modified “iliotibial tenodesis” procedure, to those patients with a persistent pivot shift following revision ACL reconstruction improved the stability of the knee, and functional outcome (Porter et al Am J Sports Med 2018). However, it is not known if this is case when there is a persistent pivot shift, following primary ACL reconstruction. The goal of this study is to determine if the functional outcomes are improved when the ITBT procedure is added to the ACL reconstructions in patients with a positive pivot shift test, following primary ACL reconstruction. The study is a RCT in which patients who meet the study criteria (skeletally mature, physically active, medically fit, no previous knee surgery, isolated ACL rupture at the time of surgery, pivot shift test one grade or more in the reconstructed knee greater than that of the un-injured opposite knee, no previous ACL injury or surgery in either knee) are randomized to either have this procedure added to their ACL reconstruction (group 1) or not (group 2). The randomization is performed using a computer program, at the time of surgery. The ACL reconstruction is performed in a standard manner and as described in the literature (Porter et al. OJSM) using ipsilateral autologous hamstrings, with interference screw fixation in both the femur and the tibia. The modified ITB tenodesis procedure (ITBT) is performed using a 10cm long incision of the distal ITB and its insertion onto Gerdy’s tubercle. A 1cm distally based strip of the ITB is harvest. The free end is prepared with a locking whip-stitch and the passed from superficial to deep around the proximal lateral collateral ligament of the knee, and secured into a bone tunnel at the posterior aspect of Gerdy’s tubercle. The ITBT is tensioned to correct the pivot shift to 0 before securing with an interference screw in the tunnel at Gerdy’s tubercle. All interference screws are made of biohydroxy-apatite and undergo osseous integration within 12 months of surgery. The outcome of interest is the following patient-reported outcomes, the IKDC (international knee documentation committee), the KOOS (knee osteoarthritis and injury outcome study), the Lysholm score, and Tegner activity score, all of which have been validated for this use and have been used before in similar research. The questionnaires take patients approximately 15 minutes to complete. The PROs are completed prior to surgery, and again at 1, 2, 5, 10 and 15 years post surgery. The data will be analyses using statistical analysis, with P<0.05 used to denote statistical significance. The occurrence of any complications and / or recurrence of ACL injury is also noted at each of these time intervals.

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.