ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32850 results sorted by trial registration date.
  • The efficacy of topical preparations in reducing the incidence of P. Acnes in total shoulder arthroplasty

    Elective total shoulder arthroplasty (TSA) is a common and effective orthopaedic procedure for the treatment of osteoarthritis and rotator cuff injuries. Infection remains a common reason for surgical revision. A common bacteria causing these infection is Propionibacterium Acnes. The current method to reduce post op infections is to use skin preparations prior to surgery. This standard surgical prophylaxis does not seem to decrease the bacterial load. This may be a potential source of infection for susceptible patients having procedures with surgical implants. Benzyl Peroxide (BPO) and Benzyl Peroxide/Clindamycin (BPO/C) topical skin preparations have been shown to reduce the superficial skin colonization of P. acnes. This study aims to investigate the use of BPO and BPO/C as a topical skin preparation and to determine the effects it has in reducing positive cultures in patients undergoing TSA. Study Outcomes • Contamination and inoculation with P. Acnes will be determined via microbiological analysis. Positive cultures will be noted and compared statistically between groups. From this data efficacy between preparations can be determined. • Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.

  • Anti-chlamydophila antibiotic combination therapy in the treatment of patients with Coronary Heart Disease

    The purpose of the study is to see whether the antibiotic combination of 100mg doxycycline, 500mg azithromycin and 300mg rifabutin is a safe and effective treatment for coronary artery disease which has not responded to "standard" treatment. Coronary artery disease is the process of plaque build up within the walls of the arteries responsible for the supplying the heart with oxygen and nutrients. Plaque is usually made up of fatty deposits, minerals and various amounts of tissue and white cells which eventually narrows the artery, reducing blood flow to the heart. The resulting damage and build up of fat results in inflammation of the arterial wall and eventually the arteries narrow. The researchers involved in this study consider that a pathogen called Chlamydophila pneumonia, which can live inside cells, may cause this inflammation of the arterial wall. The purpose of this study is to see if treatment with this antibiotic combination in patients with CHD is safe and effective in reducing disease severity measured at coronary angiography and improving quality-of-life. Approximately 60 patients will be involved in this trial. The treatment period is 90 days, with a further 90 day follow-up period.

  • Study of Negative Pressure Wound Therapy as an Adjunctive Treatment for Acute Burns in Children - A Randomised Controlled Trial

    Background: Although Negative Pressure Wound Therapy (NPWT) has become widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has never been adequately investigated, with research in children particularly lacking. There is limited evidence, however, that NPWT might benefit paediatric burns patients, amongst whom scar formation, wound progression, and pain continue to present major management challenges. The purpose of this trial is to determine whether NPWT in conjunction with standard therapy accelerates healing, reduces wound progression, and decreases pain more effectively than routine treatment alone. Methods: A total of 96 paediatric burns patients will be recruited for this trial. To be eligible, candidates must be under 17 years of age and present with a thermal burn covering <5% of their total body surface area to the participating children’s hospital within 7 days of their injury. Facial and trivial burns will be excluded. Following a randomised controlled, parallel design, participants will be allocated to either an active control or intervention group. The former will receive standard therapy consisting of Acticoat™ and Mepitel™, secured with Hypafix™. The intervention arm will be treated with silver-impregnated dressings in addition to NPWT via the RENASYS TOUCH™ vacuum pump. Participants will undergo dressing changes every 3-5 days until the point of healing. The primary endpoint will be time to re-epithelialisation. Secondary outcomes include pain, pruritus, wound progression, cost effectiveness, ease of management, treatment satisfaction, and adverse events. A linear mixed model will be performed to determine the evolution across time and between groups in primary and secondary outcomes, with patients as random effect. Wound fluid collected during NPWT will also be analysed to generate a proteomic profile of the burn microenvironment. Discussion: The study will be the first randomised controlled trial to explore the effects of NPWT on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management.

  • Gluteal tendinopathy Education (GTED): a randomized control trial

    Gluteal tendinopathy (GT) is a common, debilitating musculoskeletal condition, most often seen in middle aged females, and sedentary overweight people. The resultant lateral hip pain leads to reduction in physical activity and often poor sleep, which may impact on general health and well-being, as well as quality of life and employment status. It has been proposed that compressive loading is a factor that contributes to the development of insertional tendinopathy. Compressive loading of the gluteal tendons occurs between the iliotibial band (ITB) and the greater trochanter in positions of hip adduction. Daily postures, such as sitting with knees crossed, standing ‘hanging on one hip’ in adduction, and side-lying, may contribute to cumulative compression on the tendons. The impact of this can be imparted to the patient through education, which has been proposed as a key component of load management. Tendon loading can be controlled by postural changes, avoidance of aggravating activities, and regulation of physical activity volumes and intensities. Most literature suggests a multimodal program of education in addition to appropriate exercise prescription. A randomized controlled trial recently demonstrated that a multimodal load management program in the form of advice and practical strategies in addition to exercises in GT was superior in terms of pain reduction and perceived rating of improvement in the overall condition to corticosteroid injection or a wait and see approach in both the short and long term. To date, the impact of load management through education alone has not been investigated. Therefore, the primary aim of this study is to: 1.Investigate the efficacy of online education/information material on global rating of change in individuals with gluteal tendinopathy. The secondary aims of this study are to: 2. Evaluate the patients’ perceptions of the education brochure by assessing quantitative and qualitative questionnaires at 6 weeks. 3. Assess possible prognostic variables of pain and disability for gluteal tendinopathy at 12 months

  • ICUTogether a web based recovery program for intensive care survivors: a randomised control trial

    Annually, hundreds of thousands of people survive a life threatening event/illness and require admission to an intensive care unit. Many of those will experience significant and life changing psychological complications as a result. There are no evidence based recovery programs available within Australia or throughout the world which could help reduce the risk of these complications developing. This intervention study will evaluate a mobile health (m-health) recovery program by measuring the emotional and psychological well-being of participants over time. Outcome measures will include incidence and severity of anxiety and depression, Post-Traumatic Stress Disorder and health related quality of life.

  • Comparing levels of pepsin in saliva with 24­-hour probe monitoring in patients clinically diagnosed with Laryngopharyngeal Reflux (LPR)

    Aim: To demonstrate the usefulness of two tests for laryngopharyngeal reflux (pH/Impedance and Oral Pepsin ELISA) Participants: 50 adults (>18 years) with a clinical diagnosis of laryngopharyngeal reflux (LPR) presenting to ENT/laryngology clinic. Method: Informed consent will be gained from participants, who will be asked to first complete two forms related to their experience of reflux (Belafsky Reflux Symptom Index (RSI)& Vocal Tract Discomfort Scale). Participants will then have a 24­hour dual pH/Impedance probe placed in clinic, confirmed by either manometry (preferred) or direct visualised pullback (DVP) method ­ depending on final departmental budgeting. During this 24 hr period, up to 5 salivary samples will also be collected: 1x upon waking and standing but before breakfast and teeth­brushing, 1x 60minutes after lunch and 1x 60 minutes after dinner. The fourth and fifth samples may be collected following symptoms being experienced by the patient. After 24 hours the probe will be removed and the salivary samples will be returned to the clinic, refrigerated at 4 degrees and analysed within 2 days. We expect to see increased diagnostic value of combing the results of these two tests.

  • (M)ultifactorial (I)ntervention in Patients with (P)eripheral (A)rterial (D)isease - A Randomised Controlled Trial

    There are clinical trials that have examined the benefits of supervised exercise training in addition to “optimal medical care” in peripheral arterial disease (PAD). However, aggressive risk factor modification was not the focus, as it has been in other (non-PAD) cardiovascular studies. This randomised controlled trial will evaluate the impact of a systematic physician-led approach to aggressive risk factor modification in PAD. Hypothesis: A multifactorial intervention in patients with PAD, compared to standard practice, will lead to improved functional status (as assessed by maximum walking distance [MWD]), cardiovascular risk factor control, and quality of life (as measured by Peripheral Artery Questionnaire). This systematic physician-led program will increase adherence to guideline-based therapies. There will be beneficial effects on the atherosclerotic disease process (as measured by exploratory biomarkers of inflammation). TRIAL DESIGN This is an investigator initiated, local, multicentre, randomised controlled trial in South Australia. A total of 150 participants will be randomised into two groups. The intervention arm (group A) will undergo multifactorial intervention under a physician-led program of behaviour modification with stepwise introduction of pharmacologic therapy. This group will have follow-up over a 12-month study period. The follow-up frequency will be up to the discretion of the study physician. The standard therapy arm (group B) will have conventional treatment (e.g. follow-up with general practitioner and/or vascular surgeon) for the length of the 12-month study period. These patients will be offered multifactorial intervention after completion of the protocol. The clinic reviews and investigations in this study are intended to complement standard practice. All participants will continue to see their usual treating clinicians throughout the study period.

  • A Phase 1 Study of Two PRN1008 Tablet Formulations and the impact of Midazolam and Famotidine on PRN1008 in Healthy Subjects

    PRN1008-011 is a single center, four-period, open-label, randomized, complete cross-over study in healthy adult participants.This study will evaluate the relative bioavailability of two novel formulations of PRN1008 (Test Formulations #1 and #2) compared to an existing tablet formulation (Reference Formulation), which has previously been administered in Phase 1 and Phase 2 studies. The information obtained in this study will evaluate the potential of the two novel formulations for use in future PRN1008 patient studies, and determine if any dosage adjustments are needed to obtain similar plasma exposures between the formulations. PRN1008 is a novel, reversible covalent, investigational drug that inhibits Bruton’s agammaglobulinemia tyrosine kinase (BTK). PRN1008 acts as an adenosine triphosphate (ATP) competitive inhibitor that is both potent and selective for BTK. PRN1008 has a slow off-rate for binding to the target site, resulting in prolonged target occupancy relative to its low systemic exposure. This study will also evaluate the PK of PRN1008 when co-administered with a customary dose of famotidine, an H2-receptor antagonist. Co-administration of PRN1008 in the morning after famotidine use, as well as in the evening 2 hours prior to famotidine will be studied. A prior study (PRN1008-006) found that PRN1008, when administered in combination with a proton-pump inhibitor (esomeprazole), demonstrated approximately a 50% reduction in plasma exposure, most likely due to the impact of esomeprazole on gastric pH. Based on these results, proton-pump inhibitors are currently excluded from PRN1008 clinical trials. The objective of this evaluation is to assess the potential impact of co-administering PRN1008 with H2-receptor antagonists, which are less potent reducers of gastric pH compared to proton-pump inhibitors. The results of these evaluations will inform the use of PRN1008 in future clinical studies. Finally, this study will evaluate the potential for PRN1008 to alter the PK of midazolam when co-administered under various scenarios; this information will inform the use of PRN1008 in autoimmune diseases where drugs like midazolam and other CYP 3A substrates may be co-administered.

  • Tuning in to Teens Whole School Approach: Examining the efficacy of an emotion-focused intervention aimed at adolescents, parents, and teachers in preventing youth mental health difficulties

    The Tuning in to Teens program (Havighurst, Harley, Pizarro & Kehoe, 2012) is a program aimed at improving emotion socialisation to promote adolescent development of emotional competence and strengthen parent-adolescent relationships. The program has shown to be efficacious in helping parents' develop skills in recognising, understanding and responding to emotions in themselves and to their teen and to reduce adolescent mental health difficulties, such as internalising and externalising problems.. This study evaluated a whole school approach version of the evidence-based Tuning in to Teens parenting program, targeting parents, teachers and year 8 & 9 students. This allowed directly teaching emotion regulation skills to teens, as well as helping their parents, teachers and peers learn ways of responding that assist the young person with their emotional development.

  • Performance of a new preloaded fiducial needle for guided radiation therapy of upper gastrointestinal cancers

    Image guided radiotherapy (IGRT) has recently emerged as a technique for delivering high doses of radiation accurately over a short time span. It has advantages over conventional external beam radiation (EBRT) by minimising radiation exposure to the surrounding tissues and thus potentially reducing toxicities. This has been utilised at a variety of sites, including the pancreas, oesophagus, lung and prostate. Image guidance is best achieved with the implantation of target markers called fiducials or seeds. These are typically composed of gold and there are currently several available on the market. In pancreatic cancer, fiducials are superior to biliary stents in terms of showing tumour position. The technique for implanting fiducials has traditionally been done percutaneously or surgically, but such approach often limited by its invasiveness or the deep location of the cancers such as those from the esophagus or pancreas. Given the ability of EUS to reach these “difficult” organs, the efficacy and safety of EUS guided fiducial insertion for these GI malignancies have been demonstrated recently. The technique of inserting fiducials almost identical to that of FNA/FNB. Compared to percutaneous method, EUS guided fiducial insertion is likely to associated with a reduction in peritoneal seeding risk and obviates the need to traverse other organs. Up to now, 10mm gold Visicoils of various diameter is the fiducial system for EUS insertion. This approach, however, requires individual loading of a single fiducial to the tip of a FNA needle prior to each single deployment, which is tedious and time consuming. More recently, Cook Medical has specifically designed a dedicated 22G EUS guided fiducial needle with 4 x 5mm gold bars preloaded at the tip of the needle. This allows the fiducials to be deployed to target lesions consecutively in a short amount of time, and avoid the need of withdrawing the needle to load the subsequent fiducials. In live porcine model, the use of this needle prototype was associated with safety, high technical success rate and high visibility score on fluoroscopy. Who can participate? Recruitment for this study was done on a retrospective and prospective basis. Data on patients who underwent EUS-guided fiducial placement for SBRT or brachytherapy for GI malignancies were recruited over a 4 year period. Only patients with confirmed malignancy by a cytopathologist and able to give informed consent were included. Aim: The aim of this study is to compare the performance of a new EUS preloaded fiducial needle (Cook Medical) against the conventional coil fiducial (Visicoil) for SBRT and brachytherapy. Hypothesis: It is hypothesized that the new EUS guided preloaded fiducial needle will perform just as well as the conventional coil fiducial, with a 100% technical success rate.

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