ANZCTR search results

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

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32847 results sorted by trial registration date.
  • Development and evaluation of a nursing risk assessment manual handling training program for moving patients with a stroke and other conditions affecting mobility: The Risk Assessment for Moving Patients (RAMP) program

    Perceived gaps in patient manual handling practice by nursing staff exist and these relate to inconsistent knowledge, adherence and clinical applicability of the current program. The current manual handling program for nurses was reviewed by a working party that included subject matter experts where a new patient manual handling program, Risk Assessment for Moving Patients (RAMP), was developed for nursing staff and is focused on the patients with a stroke and other conditions affecting mobility. RAMP uses a risk assessment model and research shows this approach to manual handling may reduce staff injuries. RAMP is based on a process where staff are taught a baseline sequence of events as well as the contributing factors for a patient to be able to successfully participate in a movement / transfer. The staff are then up-skilled in how to risk assess for the patient in front of them through an analysis of the patients movement, the patient’s ability to participate (physically and cognitively), as well as observation and modification of the environment (where appropriate) and the staff resources available. The risk assessment brings together the baseline sequence of events with the risk assessment to guide safe choices for the movement / transfer as well as encouraging patients to move their own weight where safe and able to do so. The primary aim of the program is to change clinical practice of nursing staff at the bedside. The secondary aims of the program are nursing staff safety and patient falls prevention. The RAMP program is to be evaluated using the four levels of the Kirkpatrick model of evaluation, which includes reporting the participant reaction to the program (Level 1), the degree of learning achieved (Level 2), the transfer of the learning back into the workplace (Level 3) as well as the targeted outcomes of the education program (Level 4). It is hypothesised that the RAMP program will change clinical practice at the bedside and this change in practice may prevent patient-related musculo-skeletal injuries in nursing staff and reduce patient falls on the pilot wards.

  • Spinal Cord Stimulation in the treatment of chronic, intractable pain using the Nalu Neurostimulation System in adults

    The Nalu Neurostimulation System is indicated as an aid in the management of chronic intractable pain. The study will enroll adults between 21 and 80 years of age with chronic intractable pain in the legs and/or back, who meet the inclusion and exclusion criteria of the study. The primary study objective is to confirm the performance of the Nalu Neurostimulation System in patients with chronic pain. Additionally, multiple standard outcome domains will be captured to confirm system performance and patient responses to the device and therapy. Data will also be collected to support a safety endpoint. The study is a prospective, multicenter, open label, feasibility clinical study. The study will include three phases: Screening/baseline, SCS Trial, and Permanent Implant. Study subjects will be followed up for 12 months after device implantation. The study is expected to take 2 years from first enrollment to last follow up of last patient and subsequent study closure. Upto 40 subjects will be implanted with the device across 10 centers in Australia and New Zealand. Performance measures include Pain Scores(VAS, Numeric Rating Scale, in-office and at home); Quality of Life using the EQ5D, Activities of Daily Living (Oswestry Disability Index, ODI), Pain and paresthesia maps, pain medication use, procedure information, ease of use of the wearable components, Brief Pain Inventory and the Beck's Depression Index. This study is not formally powered as it is a feasibility study. basic statistical analyses will be completed on all endpoints including computation of average, variance , standard deviations and trend analysis. Secondary Objective data may be qualitative only.

  • The influence of snacking on promoting weight loss and protecting against weight regain in overweight and obese adults.

    The primary aim of this project is to investigate whether the inclusion of different types of snack foods in an energy restricted diet (i.e. a diet that provides fewer kilojoules than you currently consume) improves weight loss and limits weight regain. We are also interested in seeing whether there are improvements in cardiovascular, liver and gut health and quality of life and functional mobility. We hypothesize that consuming almonds as a snack, when compared to carbohydrate-rich foods, will lead to greater weight loss during the energy restriction phase and will be more effective at limiting weight gain during the weight maintenance phase.

  • The effect of early feeding into the gut on gut function after major colorectal surgery

    The purpose of this study is to determine whether early feeding can help decrease gut side effects in patients who have received surgery for the removal of all pelvic organs (called pelvic exenteration and includes removal of the bladder, urethra, rectum and anus) as a radical surgery for the treatment of cancer. Who is it for? You may be eligible for this study if you are an adult who is going to have a pelvic exenteration surgery for cancer and other curative reasons. Study details Participants in this study will undergo their surgery as normal, and then during the surgery, will be randomly selected to be one of two groups. Group 1: Will receive standard nutritional care after the operation. Group 2: Will receive a feeding tube during the surgery, which will commence providing food within 24 hours from the end of the surgery up until the participant commences a full fluid diet. Tolerance and delivery of nutrition will be monitored. It is hoped that this research will help determine if it is possible to commence feeding patients after their pelvic exenteration surgery and therefore reduce gut-related side effects.

  • Self-reported daytime sleepiness and sleep-disordered breathing in patients with Atrial Fibrillation

    Sleep-disordered breathing (SDB) is common in patients with atrial fibrillation (AF) and is associated with poor clinical outcomes. International AF management guidelines advocate for the interrogation for clinical signs of SDB when addressing AF risk factors given the important interplay between SDB and AF. Excessive daytime sleepiness is an important clinical consequence of SDB and its presence can be a key consideration in patient selection for SDB investigation and management. However, patients with cardiovascular disease report low levels of daytime sleepiness. Therefore, relying on self-reported daytime sleepiness in patient selection for diagnosis and management can potentially result in a significant proportion of patients not being identified with SDB or provided appropriate management opportunities. We hypothesise that in patients with atrial fibrillation, excessive daytime sleepiness is low and that self-reported sleepiness correlates poorly with the presence or degree of SDB. We aim to test this hypothesis by studying patients with AF who have undergone overnight sleep studies. We will assess the self-reported sleepiness and its correlation to the presence and degree of SDB. We will test the utility of the Epworth Sleepiness Scale, a widely used tool to quantify daytime sleepiness, to predict the presence of SDB. Further, we aim to characterise clinical features that can help identify patients with significant SDB, and assess the potential impact this would have on AF management.

  • Can Heart attack patients without coronary artery blockages benefit from standard heart attack medical treatment strategies?

    Myocardial infarction with non-obstructive coronary arteries" (MINOCA) occurs in 5-10% of all patients with acute myocardial infarction (AMI). There are neither any randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI, nor any treatment guidelines. The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether Angiotensin Converting Enzyme Inhibitors (ACEI/ Angiotensin Receptor Blockers (ARB) compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with MINOCA and with no clinical signs of heart failure and with left ventricular (LV) systolic ejection fraction above or equal to 40%.

  • MRI follow-up of patients following leukocyte-rich platelet-rich plasma injections for chronic gluteal tendinopathy of the hip

    Gluteal tendinopathy is a degenerative condition of the hip. A recent randomized control trial showed that a single injection of platelet-rich plasma was associated with improvement of gluteal tendinopathy. This study will aim to assess whether imaging changes can be identified in the study population. The aim is to assess whether single LR-PRP or corticosteroid injection for gluteal tendinopathy results in improvement in gluteal tendon appearance on MRI at 2 years post intervention. The primary outcome measure will be statistically significant improvement in tendon imaging abnormalities on 2 year follow up MRI compared to pre-treatment MRI. MRIs will be reviewed and graded by an experienced radiologist. Gluteal tendon changes will be graded based upon a previously published gluteal tendinopathy MRI grading score. A secondary outcome measure will be statistically significant correlation with clinical improvement as described in the original randomised control trial by Fitzpatrick et al . This will be a single-centre trial conducted as a follow up of a double-blind randomised control trial. The subjects will be all subjects from the double-blind randomised control trial that weren’t lost to follow up along with those who were in the open labelled extension to the trial who had a pre-study MRI. An experienced radiologist will assess pre and post LR-PRP RCT MRI using a validated grading system. The radiologist will be blinded to the identity of the patient and to which post-trial MRI relates to which pre-trial MRI. Once the imaging has been scored statistical analysis will be used to determine whether the changes are significant. They will also be compared to the clinical changes seen in the randomised control trial to assess any statistical correlation in the two measures.

  • A peer support program for the long-term maintenance of physical activity and health outcomes in breast, prostate and colorectal cancer survivors

    The purpose of this study is to determine whether a structured peer support program can improve exercise adherence and health-outcomes in breast, prostate and colorectal cancer survivors. Who is it for? You may be eligible for this study if you are an adult with confirmed breast, prostate or colorectal cancer, and are at least one month post-treatment completion for cancer. Study details All participants will undertake an initial 4-week supervised training phase, with 3 sessions per week of exercise with an accredited exercise physiologist or equivalent. Following the supervised phase, participants will enter a 1-year maintenance period where they will be asked to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. Participants will be randomly assigned to either receive peer support or no peer support during the maintenance phase. It is hoped that this research will help determine if a peer support program is effective in enhancing exercise adherence and long-term health outcomes in cancer survivors.

  • Greater trochanteric pain syndrome shoe insert study

    People who have hip pain frequently report pain with walking and climbing stairs or hills. We want to know if using shoe inserts (orthotics) can change the level of discomfort that people with hip pain report. Using the Gait Laboratory at the University of Canberra, we will evaluate if real or sham shoe inserts changes the way people walk. Further, we’ll give people a shoe insert to use for four weeks to see if this helps with their hip pain and their walking, and reassess them after this time. Our hypothesis is that the use of shoe inserts will reduce hip pain with walking.

  • Does cannabidiol reduce severe behavioural problems in youth with intellectual disability? Feasibility and pilot randomised placebo-controlled trial.

    This is a single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants comparing 98% cannabidiol oil (CBD) with placebo in reducing Severe Behavioural Problems (SBP) in children aged 8 – 16 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo. The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, tolerability of the study medication, study duration, study procedures and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized clinical trial of CBD to reduce SBP in children with ID. The secondary objectives of this study are to assess the safety of the administration of oral CBD in children aged 8 -16 years with ID and SBP.

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