ANZCTR search results

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

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31373 results sorted by trial registration date.
  • Ultrasound measurement of unstable shoulders before and after taping and rehabilitation treatment

    This is the second component of a masters project that is investigating humeral head position and translation in unstable shoulders. In this pre- and post-intervention study, we aim to investigate the effect of taping and rehabilitation on humeral head position and/or translation in unstable shoulders. We hypothesise that humeral head inferior position/translation will reduce and that these findings will correlate with other measured improvements of shoulder position, strength, pain, and function.

  • RED Penumbra System Registry

    This will be a prospective, single-arm, multiple center observational registry which will include patients in whom the Penumbra RED System is used as part of a mechanical thrombectomy procedure to treat intracranial large vessel occlusion presenting with acute stroke. Baseline patient information, relevant co-morbidities, stroke clinical data, procedural data, imaging (CT, DSA, MRI) data, periprocedural complication data, and clinical follow-up information at 90 days will be collected. There is no alteration to the standard of care at the participating site. The purpose of the registry is to collect and analyse data regarding the efficacy and safety of the TGA approved range of Penumbra RED thrombectomy catheters used with the Penumbra Aspiration Tubing and the Penumbra Machine suction pump (referred to together as the Penumbra RED System) that are already in clinical use at the participating sites.

  • A comparison of disease activity, quality of life and costs following implementation of a digital monitoring strategy in rural patient with inflammatory bowel disease

    This study will compare the impact and acceptability of a digital strategy utilising IBD specific smart phone apps, to standard IBD practice, in the delivery of care to patients from a regional area in Queensland, Australia. We aim to determine the impact of a digital monitoring strategy on quality of life, disease symptoms and costs of care. Participants will be recruited from a regional IBD clinic in Queensland Australia. The trial will run for approximately 15 months. We anticipate that the Implementation of the digital strategy will be non-inferior to standard of care in terms of both patient symptoms and quality of life, whilst reducing health care associated costs.

  • Effects of combined arm and leg high-intensity interval training on motor and non-motor symptoms in people with mild to moderate Parkinson's disease: A randomised controlled feasibility trial

    An 8-week randomized feasibility trial will be conducted to investigate motor and non-motor responses to high-intensity interval training utilizing a combined arm and leg ergometer in individuals with mild to moderate Parkinson's disease (PD). control group will receive usual care. Primary hypothesis High-intensity combined arm and leg ergometry added to usual care will lead to increases in habitual gait speed in people with PD compared to usual care.

  • Knee Injection Study at St George Hospital (KISS) for the Treatment of Knee Osteoarthritis

    There is currently no disease-modifying agents available for knee osteoarthritis and treatment focuses on relief of symptoms such as pain and stiffness. There is limited placebo controlled randomised clinical trial data for a number of procedures to improve symptoms of knee osteoarthritis to improve function. These include steroid injections into the joint and blocking the nerves that supply the joint. These interventions have not been adequately studied against placebo. This study will look at comparing the effectiveness and safety profile of these two technqiues agents against a shared placebo group to see if they are effective. A further exploratory outcome is how well these interventions compare against each other if they prove effective against placebo.

  • Efficacy of REducing cardiometabolic risk with SEmaglutide in Type 1 diabetes

    Premature cardiovascular disease is the leading cause of death in people living with type 1 diabetes. Semaglutide, a long-acting glucagon-like peptide-1 receptor agonist, has been shown to reduce cardiovascular events and improve weight and glycaemia in type 2 diabetes. Semaglutide may offer cardioprotective and metabolic benefits in type 1 diabetes. Our study hypothesis is that semaglutide will reduce carotid femoral pulse wave velocity, a measure of arterial stiffness. Arterial stiffness has been shown to be an appropriate surrogate marker of cardiovascular risk in this population. Subjects will receive semaglutide 1.0mg weekly or matched placebo for 26 weeks. Potential mechanisms for metabolic changes will also be explored including insulin sensitivity determined by hyperinsulinaemic-euglycaemic clamp; and incretin and pancreatic hormone levels determined by mixed meal tolerance test. We will also study incretin and pancreatic hormones determined by mixed meal tolerance test in a group without diabetes to compare to the group with type 1 diabetes.

  • A Pilot, Safety, Efficacy and Feasibility Double-Blind Randomised Controlled Trial of Scp776 for Neuroprotection in Comatose Adults Resuscitated After Out-of-Hospital Cardiac Arrest

    Cardiac arrest is a common and catastrophic event. Among survivors of cardiac arrest, many have ongoing problems in thinking and performing normal activities of daily living. Such difficulties may arise from lack of oxygen to the brain causing injury that occurs as a result of the cardiac arrest. Therapeutic interventions that can be applied to lessen the degree of brain injury after cardiac arrest are warranted and desperately needed. Insulin-like growth factor-1 (IGF-1) is a major growth factor and has been shown to play a role in recovery from ischemic damage due to its anti-cell death signaling activity. Scp776 is a first-in-class targeted growth factor therapeutic that selectively activates and prolongs insulin-like growth factor-1 receptor (IGF-1R)-driven pro-survival signaling in damaged tissues containing large numbers of apoptotic cells. As such, by conducting a multi-centre randomsied trial, we aim to determine whether treatment with scp776, compared to placebo, decreases the extent of brain injury as calculated by automated assessment of brain magnetic resonance (MR) imaging (RAPID Software) at 72 – 96 hours following randomisation in comatose adults resuscitated after out-of-hospital cardiac arrest. This study will enrol a total of 40 evaluable participants from 5 - 10 hospitals in Victoria, Australia. The primary outcome will be ascertained between 72 - 96 hours after randomisation. Study participants will be followed-up for 180-days post-randomisation, or death, whichever is earlier.

  • Myocardial Infarction in the Young: A Prospective Clinical Registry Study

    Myocardial infarction (MI) affects -57,000 Australians every year and almost half a million Australians have had a heart attack at some point in their lives. While mortality after MI has been declining over the last few decades, it is in the group of young patients that it has lagged. Data on the biological and pathophysiological factors related to MI in the young is scarce. In addition, there are gaps in quality of care due to the perceived risk for MI being low. The study aims to characterise the clinical presentation, risk factors, angiography findings, underlying aetiology, quality of care and sex differences, of young patients with MI (age <50 years). This is an investigator-initiated, observational, single-centre clinical registry study. Approximately 500 patients under the age of 50 years with MI will be either recruited Prospectively from Westmead Hospital.

  • Effect of 8-week prebiotic supplementation on gut health in Prosthetic Joint Infection patients

    Prosthetic joint infection (PJI) is a catastrophic complication of orthopaedic joint replacement surgery that is increasing in incidence despite current best-practice. The success rate of treating Prosthetic Joint Infections (PJI) ranges from 0 to 89%, and the median cost per patient in Australia is $34,800, with a 156% increase in treatment cost when the treatment fails. Emerging evidence suggests that Gut dysbiosis i.e altered gut microflora is associated with absence or reduced abundance of beneficial microorganisms, increased abundance of pathogens and could predispose patients to a higher risk of PJI post orthopaedic procedures. Supplementaion with suitable prebiotics (non-digestable carbohydrates) results in production of short chain fatty acids that alters gut microbiome favourable. Hence, in this study, we will be investigating the effect of modifying gut microbiome with an in-market prebiotic supplement on surgical outcomes and recovery in PJI patients.

  • Evaluating the use of digitally enhanced treatment models in early intervention for youth with bipolar disorder.

    Currently, specialised early interventions are not accessible for a majority of youth with Bipolar Disorder (BD) who seek care. To address this gap, we have developed a bipolar-specific model of care for those with early-stage BD (BLEND) integrating: (i) evidence-based psychological strategies delivered through digital and face-to-face sessions; (ii) psychopharmacological interventions; (iii) relapse prevention strategies, and (iv) online peer support networking. We will conduct a randomised trial to evaluate the effectiviness of BLEND, compared with an enhanced form of standard care (ESC). We will include young people aged between 15 and 25 years, seeking specialised help for Bipolar Disorder types I or II. After informed consent, we will randomise 125 such young people (1:1) to BLEND or ESC. Interventions will be delivered over 4 months and assessments will be conducted at Baseline, 2, 4, 6 and 8 months from Baseline.

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