ANZCTR search results

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

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32721 results sorted by trial registration date.
  • Developing resilience and positive mental health strategies in university students

    Suicide is a leading cause of death among young Australians. Historically, high levels of suicide have been recorded in Australian university students, as they transition from high school to university, and experience dramatic changes in personal and social circumstances. The National Suicide Prevention Program in Germany recently developed the “Talk to Me” program, a suicide prevention intervention that facilitates the detection of early symptoms of evolving suicidal behaviour and supports action planning in a potential suicidal crisis situation. This research aims to develop, deliver and test the "Talk-to-Me" Mass online learning content (MOOC) for undergraduate university students, underpinned with strength-based suicide prevention principles.

  • The effects of physical exercise on the brain and the immune system in individuals with chronic pain.

    While evidence in healthy individuals demonstrates that exercise improves health outcomes and exerts biological effects, the effects in individuals with chronic pain are poorly understood. Exercise interventions have been suggested useful in reducing pain, however evidence shows that effects vary in magnitude and direction. This project aims to improve the understanding of the central neurobiological and immunological effects of exercise in individuals with chronic pain. Individuals with chronic whiplash will participate in either an aerobic or resistance exercise intervention, allowing for a direct comparison informing on the type and dosage considerations of exercise prescription. Magnetic resonance scans and immunological factor concentrations will inform on the underlying effects of exercise. A single-case experimental design with sixteen participants allows for an evaluation of the feasibility, as well as the effectiveness of isolated elements of this intervention. Determining the underlying mechanisms is the first step in understanding the effects of exercise in individuals with chronic pain. Outcomes will therefore benefit researchers and clinicians aiming to improve health outcomes in individuals with chronic pain.

  • Effect of RTB101 on Respiratory Illness Associated with Laboratory-Confirmed Pathogens in the Elderly

    The purpose of this study is to determine if RTB101 helps decrease the percentage and rate of clinically symptomatic respiratory illness that are either confirmed by laboratory test or not. The study will also find out whether it decreases the duration of moderate and severe symptoms due to all clinically symptomatic respiratory illness that are confirmed with a laboratory test. The study will also see if RTB101 is safe to use. The study will also look at rate of respiratory illnesses that occur with specific viruses.

  • A blended face-to-face and smartphone intervention for suicide prevention in the construction industry (MATESMobile): protocol for a randomized controlled trial with MATES in Construction.

    Construction workers are at elevated risk of suicide. MATES in Construction (MATES) is one of the few suicide prevention programs that explicitly address this problem. The MATES program includes an integrated system of services that supports prevention, early intervention and recovery (i.e., primary, secondary and tertiary prevention) for mental health problems among construction workers. In this protocol, we describe a proposed evaluation of MATESmobile, an electronic platform which will be accessed by workers who have undergone MATES training. In this protocol, we describe a Randomised Controlled Trial (RCT) which seeks to assess whether MATESmobile results in improved literacy regarding suicide prevention, and improved help-seeking and help-offering attitudes among those who have attended MATES training. Secondary outcomes include changes in suicide ideation, suicide attempt and psychological distress. Workers will be recruited prior to MATES face-to-face training. In total, 295 workers will be randomly assigned to the intervention condition (MATESmobile + face-to-face training) and 295 will be randomly allocated to the control (face-to-face training). The intervention will run for 8 weeks. Assessments will be run immediately post intervention, and at 3, 6, and 12 months. MATESmobile offers the potential to reinforce and enhance the effects of face-to-face training, resulting in greater skills and knowledge in suicide prevention, as well as a reduction in suicidality and distress.

  • Endoscopic Management of Weight Regain post Gastric Bypass

    Dilated Gastrojejunal stoma can lead to weight regain after gastric bypass surgery. Endoscopic revision with endoluminal suturing or argon plasma coagulation is currently performed as a first line treatment in the United States, given that surgical revision is associated with significant risk of complications. Studies have demonstrated that endoscopic intervention is effective, safe and most patients avoided surgery. In this study, we aim to describe our experience in endoscopic techniques used to treat weight regain after gastric bypass surgery. Our overall objective is to assess the long-term outcome of endoscopic intervention at a tertiary referral centre.

  • An open label, study to evaluate the safety of Cannabidiol (CBD) for the prevention of Acute Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic cell transplantation.

    The purpose of this study is to evaluate the safety of cannabidiol (CBD) for the prevention of Acute Graft-Versus-Host Disease (GVHD) in patients who are undergoing allogeneic hematopoietic cell transplantation. Who is it for? You may be eligible for this study if you are aged 18 or older, and are undergoing a allogeneic hematopoietic stem cell transplantation (HSCT). Study details Participants in this study will consume a solution of cannabidiol (CBD) in olive oil by mouth twice per day from the time transplant procedures commence until 98 days post-transplant. The concentration of CBD will vary depending on when you enrol in the study. As part of his study, all participants will have blood and urine tests, and undergo physical examinations, in addition to standard post-transplant tests. It is hoped this research might provide some evidence that CBD can prevent acute Graft Versus Host Disease (GVHD) in patients that have undergone an allogeneic HSCT, including how it is tolerated, absorbed and interacts within the body.

  • Knee bracing for medial arthritis of the knee

    This study will use patient-specific, electromyogram-informed neuromusculoskeletal modelling to determine the immediate effects of an Ossur Unloader One knee brace on medial knee joint contact force during walking in 30 people with established medial knee osteoarthritis and who have outward (varus) knee alignment. A secondary aim is to determine the short-term (8 week) effects of the valgus brace on symptoms and joint forces. This study will test the hypotheses that medial knee joint force during walking will reduce immediately wearing an Unloader One knee brace compared to not wearing the knee brace; and 2) braced walking following daily use of an Unloader One knee brace over 8 weeks, compared to braced walking at baseline.

  • A study of the local anaesthetic lidocaine and the antibiotic doxycycline to help protect the blood vessel lining in patients undergoing heart surgery.

    Heart surgery is known to cause damage to the inner lining of blood vessels called the "endothelial glycocalyx". This damage can affect bleeding, swelling and inflammation which can harm organs and delay recovery after surgery. Damage to this layer can be measured using special blood tests. Currently there are no drugs used to protect this layer during surgery. Some experiments have shown the commonly used local anaesthetic "lidocaine" and the antibiotic "doxycycline" may be of benefit to protect this layer. We propose a project in which patients undergoing heart surgery are randomly allocated to receive one or other of the medicines or neither (a "control" group). Blood tests will indicate if these medicines have an effect on this layer. We hypothesise that lidocaine and or doxycycline may protect the endothelial glycocalyx during heart surgery.

  • High flow humidified nasal oxygen versus face mask oxygen for preoxygenation of pregnant women – a prospective randomised controlled crossover study

    Background High flow humidified nasal oxygen (HFNO) is an emerging technology with perioperative and critical care applications. We proposed a role for HFNO in obstetric anaesthesia for preoxygenation and apnoeic oxygenation in the context of general anaesthesia for pregnant women. The potential benefit is a prolongation of safe apnoea time after induction and prevention of hypoxia in a population with an elevated risk of failed airway management. Our previous observational study investigated HFNO as a single entity and found that only 60% of our participants (term pregnant women) reached the target etO2 concentration of 90%. The median [IQR] first etO2 concentration was 91 [83-93] %. A comparison study of HFNO versus usual care (face mask oxygen) is required to inform anaesthetists about whether HFNO is a suitable alternative to current clinical practice for preoxygenation of pregnant women. Aims To examine the comparative efficacy of HFNO versus face mask oxygen for preoxygenation we aim to determine the etO2 concentration in 100 women in late pregnancy at the end of protocolised preoxygenation with both systems. •Our primary aim is to assess whether HFNO is non-inferior to face mask oxygen for preoxygenation in pregnant women. We have set a clinically significant difference of 5% in etO2 concentration after three minutes of preoxygenation. •Our secondary aim is to determine if there is a difference in the proportion of pregnant women who reach the adequate etO2 concentration target of 90% with HFNO versus face mask oxygen. •Thirdly, we aim to establish an indicative reference range for etO2 concentration in term pregnant women after preoxygenation with both modalities. This will help guide future airway management recommendations specific to pregnant women. •The post-partum follow-up component of the study aims to determine the effect size (if present) of the physiological changes of pregnancy on adequacy of preoxygenation. Experimental Method We aim to recruit women in late pregnancy who will undergo two simulated preoxygenation protocols in an order based on their randomisation group. The HFNO group will undergo HFNO preoxygenation followed by face mask preoxygenation. The face mask group will undergo face mask preoxygenation followed by HFNO preoxygenation. There will be a washout period in between protocols. The participants will also be re-randomised and undergo postpartum testing according to the same two simulated preoxygenation protocols at 6 months post-delivery.

  • SCAN Study - Self Compassion & Cognitive Behavioural Therapy (CBT): Early family intervention for children with Type 1 diabetes experiencing anxiety

    This randomised controlled trial (RCT) seeks to assess the efficacy of psychological group intervention for children with type-1 diabetes and anxiety, including their primary caregiver. The intervention is an adaption of an existing manualised cognitive behavioural therapy program combined with self-compassion content and exercises. Qualified clinicians (including a clinical psychologist and either a paediatric diabetes nurse educator or a paediatric social worker) will run these group interventions (with 5-8 families at a time) at the Children’s Hospital at Westmead, Sydney. Primary Aims: Reduction in anxiety symptoms in the child (as reported by child, primary and parent/ care giver). Secondary Aims: Improvement in metabolic outcomes (HbA1c) and other psychosocial outcomes (self-compassion, diabetes self-care behaviours, parental wellbeing) We hypothesise that both parents and children will report significant improvement in the following primary outcomes compared to the waitlist control group: 1. Decreased anxiety symptoms in the child (as reported by child, and parent/caregiver) 2. Decreased anxiety symptoms in the parent/caregiver (as reported by parent/caregiver) We anticipate these changes will occur from baseline to post assessment, and be maintained at the follow-up time point (at least 3 months later). 3.2 Secondary Objectives We also hypothesise that results will show significant improvement in the following secondary outcomes compared to the waitlist control group: 1. Improved metabolic outcomes (HbA1c reading) 2. Increased self-compassion in the child (as reported by child) 3. Increased health-related diabetes self-care behaviours in the child (as reported by child) 4. Improved parental outcomes (parent’s own anxiety symptoms and self-compassion) 5. Improved child behaviour as measured by the strengths and difficulties questionnaire completed by the parent The secondary outcome of this study is to assess the practicality and feasibility of the SCAN intervention. This will be assessed by attendance records and open-ended qualitative questions about what the participants found helpful (or not helpful) about the intervention.

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