ANZCTR search results

Both indomethacin and ibuprofen are routinely prescribed to close a patent ductus arteriosus (PDA). However the effect of each medicine on cerebral circulation, is different. These differential effects may be secondary to drug specific alterations in cerebral oxygen kinetics. We propose that in order to fully understand the effect of indomethacin and ibuprofen administration on cerebral haemodynamics, it is critical to interrogate both cerebral oxygen delivery and consumption. We hypothesise that indomethacin, in comparison to ibuprofen reduces cerebral blood flow without adversely altering cerebral oxygen kinetics in preterm newborns with a clinically significant PDA.

Multi-centre Phase 2a open-labelled extension study of R-107 in MDD treatment resistant subjects who responded to treatment in the R107-C205 (BEDROC) study. Each subject will participate in up to 3 phases: • A screening phase of up to 3 weeks • An open-label treatment phase for 24 weeks • A 4-week post-treatment (follow up) phase

BTX 1503 contains the active pharmaceutical ingredient, cannabidiol in a topical liquid formulation, and is being developed for the treatment of acne vulgaris by Botanix Pharmaceuticals Limited. CBD is a member of a broader family of compounds known as cannabinoids, a class of compounds originally derived from the cannabis sativa plant. CBD is chemically synthesized under Good Manufacture Practices (GMP) for use in this study. The objective of this study is to assess safety and efficacy of various doses of BTX 1503 in subjects with moderate to severe acne vulgaris of the face. This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group, dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). Study participants will be enrolled at sites in Australia and United States of America. Not all sites will enrol paediatric participants. Participants will be randomised to one of five treatment arms: BTX 1503 5%, BID:BTX 1503 5%, QD:BTX 1503, 2.5% QD:Vehicle, BID:Vehicle QD) with 90 subjects in each BTX 1503 group and 45 subjects in each vehicle group for a total of 360 subjects. Participants will be provided with instructions for dose administration and will be asked to self-administer for 28 consecutive days. Safety and cutaneous tolerability will be assessed by the collection and review of AEs and application site review, laboratory parameters throughout the duration of the trial. Efficacy measurements will include change in inflammatory and non-inflammatory lesion counts from baseline. Photography of the face will be conducted for some participants.. Participants will remain in follow up until 84 days following the first application of investigational product, with outpatient visits at Days 1, 14, 28, 56 and 84.

Pre-operative anaemia, as defined by the World Health Organisation criteria, has a prevalence in non-cardiac surgery of around 25% and is associated with poorer outcomes peri-operatively. It also increases the chance of transfusion and increases risk of death in cardiac surgery. Blood transfusion is often used to correct peri-operative anaemia and whilst life saving in acute major haemorrhage is a limited resource and, is itself associated with morbidity and mortality. It remains unclear if treating anaemia in the peri-operative period can positively influence morbidity or mortality. However benefit from patient blood management interventions, including pre-operative anaemia optimisation, has been shown to reduce the need for blood transfusion with possible trends towards improved patient outcomes. Guidelines have been published recommending identification and active management of preoperative anaemia. An excellent goal directed review has been undertaken by the Australian National Blood Authority and also supports identification and optimisation of pre-operative anaemia. A preliminary look reviewing colorectal patients over a six month period in 2017 was recently undertaken at St George. Of the 171 elective operative cases found, ninety had a preoperative haemoglobin reported thirty of which were anaemic (33% of those who had a haemoglobin). Eight patients were transfused during the peri-operative period, the majority of whom were anaemic before surgery. This pilot study supports the published literature, and implies the problem of pre-operative anaemia is present at St George and currently insufficiently managed. Pre-operative anaemia may be an optimisable risk factor for our patients at St. George, first however we need to understand which patient groups are at greatest risk, their current management (blood product transfusions) and then how and where to focus our efforts. This work has not been previously undertaken at St George. The primary aim of the proposed study is to document the prevalence of anaemia pre-operatively and transfusion practice for all patients having a procedure in 2017 at St George Hospital. Secondary aims include the documentation of anaemia according to surgical speciality, of pre-operative iron deficiency anaemia, anaemia of chronic disease and of blood product transfusions according to patient demographics and surgical speciality. The study will also examine the timings from booking to surgery and pre-operative assessment to surgery to consider how best to optimise Haemoglobin (Hb) during the patients pre-operative pathway.

Currently, there are significant challenges in delivering health care to chronic disease populations. Our research explores the impact of early multidisciplinary supportive care for the life-limiting chronic disease population on patient and carer outcomes and healthcare resource utilisation and the utility of a multi-disciplinary supportive care clinic for such chronic conditions.

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.