ANZCTR search results

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

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33646 results sorted by trial registration date.
  • Mealtimes Matter: Childcare as window into food insecurity and food socialisation in low-income communities

    Childhood nutrition is intricately tied to trajectories of health, growth and wellbeing across the life-course. Children from low-income backgrounds have been found to be more likely to experience poor nutrition and attendant consequences including obesity. Childcare services are potential sites for intervention prior to school entry. International studies have highlighted that poor quality mealtime interactions between educators and children, including low sensitivity and mealtime rigidity, inhibit a child’s learning to like a variety of nutritious foods. This study will apply direct in-situ observation methodologies and parent survey to 1) observe mealtimes in childcare in low income communities; and 2) identify how childcare settings can support healthy food environments. The key hypothesis, tested within this study, is that positive feeding practices in childcare moderates the relationship between parent feeding practices and child eating behaviour in preschool aged children.

  • Benefits of systemically administered adjunctive azithromycin in periodontitis patients non-responsive to initial non-surgical periodontal therapy.

    Few cases of periodontitis continue to have residual periodontal pockets with bleeding on probing despite well performed non-surgical periodontal therapy. It is unclear if the use of adjunctive systemic antimicrobials can provide clinical benefits in these cases. If the adjunctive systemic antimicrobial has additional anti-inflammatory properties it may help in the modulation of the host response. Azithromycin is one such antimicrobial with additional anti-inflammatory and host-modulating properties. Although the anti-microbial properties of azithromycin have been studied extensively, there are few studies on its host-modulating and anti-inflammatory properties in the treatment of periodontitis. It is hypothesized that adjunctive administration of azithromycin results in a gain in clinical attachment levels, decreased probing depths, decrease in Periodontal Inflammatory Surface Area (PISA) scores, decreased levels of pro-inflammatory cytokines and decrease in the number of pathogenic bacteria in the periodontal pockets among patients non-responsive to initial periodontal therapy.

  • Knowledge Translation Interventions; which are most effective in upper limb rehabilitation?

    Occupational therapists and physiotherapists face challenges to providing evidence-based rehabilitation and require support to implement clinical practice guidelines. The aim of this study is to test the feasibility of two different implementation packages which aim to improve guideline adherence, and to explore effect on patient upper limb outcomes. Using a non-randomised clustered design, the study recruited occupational and physiotherapy rehabilitation services (n=3 inpatient and n=3 outpatient services) which were allocated to one of three groups: (Group A) Facilitator-mediated implementation package, (Group B) Self-directed implementation package, or (Group C) Usual care (control); we recruited n=1 inpatient and n=1 outpatient service per Group. Outcomes of feasibility, adherence to guidelines (medical file audits), and patient upper limb impairment (Fugl-Meyer Upper Extremity Assessment), activity (Box and Block Test), and practice (minutes/week) were collected at baseline and after 3-months of intervention.

  • Investigating the weight management effect of a new Probiotic Super Green Powder supplement in healthy overweight people

    Being overweight affects more than 1 billion adults worldwide and it is reaching epidemic proportions in Australia. Snacking is commonly associated with an excessive intake of high-fat and high-sugar foods, and is considered to be a predisposing factor to obesity. Even being mildly to moderately overweight (body mass index [BMI], 25-28 kg/m2) increases the risk of complications such as type 2 diabetes, hypertension and kidney disease. Although participating in calorie reduced weight loss programs and correcting inappropriate eating habits (i.e. by increasing fibre and protein content) are often sufficient in people who are moderately overweight; maintaining adequate nutrition habits over time is often difficult and thus leads to weight regain. Probiotic Super Green Powder™ is a new commercially available nutritional supplement that contains white kidney bean, blood orange and green tea extracts in addition to probiotics (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum). These active ingredients have been reported to have body weight reduction effects when looked at individually in scientific investigations. Based on these investigations, it has been hypothesized that a supplement containing a cocktail of these ingredients would influence weight reduction and snacking behaviours. The primary purpose of this study is to assess the potential benefit of using Probiotic Super Green Powder™ to sustain the commitment of overweight people trying to control their body weight over an 8-week period. The specific aims of the study will determine the effects of an 8-week supplementation period from either a Probiotic Super Green Powder™ supplement or a placebo and subsequent 4-week follow up on: - Food cravings, food preference, snacking behaviours and mood status - Body mass, body composition and waist circumference - Gut microbiota - Serum concentrations of lipid levels (including triglycerides and cholesterol) and glucose - Serum concentrations of inflammation and hormonal regulators of appetite (including C-reactive protein, ghrelin and insulin)

  • The effect of exercise on coagulation in patients with continuous flow blood pumps

    The goal of this pilot study is to evaluate whether exercise can reverse the acquired von Willebrand syndrome occurs in patients with continuous-flow left ventricular assist device (CF-LVAD). We hypothesis that increasing pulsatility (vasoconstriction process) through performing active exercise might preserve vital coagulation protein (vWF) from excessive degradation and even restore normal vWF profile. This is a prospective, single-centre observational pilot study designed to assess the effect of exercise on the recovery of a vital coagulation protein vWF in patients supported with CF-LVAD (n = 15) compare to heart transplant patients (previously requiring a CF-LVAD) (n=15) and healthy volunteers (n =15).

  • A study of the safety and efficacy of LBS-020 in patients with mouth dryness following radiotherapy

    The purpose of this study is to test a medication called LBS-020 in addressing dry mouth in patients who have undergone treatment for cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have a history of treated head and/or neck cancer, and have been diagnosed with dry mouth (also known as xerostomia). Study details Participants in this study will be randomised by chance into two groups. Both groups will use a mouthwash 5 times per day for 7 days. One group will use the intervention treatment which includes a medication called LBS-020. The other group will use an identical looking mouthwash that does not include the medication. All participants will complete a number of scales about their symptoms. It is hoped this study will demonstrate the intervention treatment can ameliorate many of the symptoms experienced by patients suffering from radiation/chemotherapy-induced chronic xerostomia.

  • An evaluation of the Mentalization- Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) in a Child and Youth Mental Health Service

    The Mentalization-Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) is a five session Mentalization Based Treatment (MBT) informed skills and education program for family members and carers of someone with Borderline Personality Disorder (BPD) (Bateman & Fonagy, 2019). MBT-FACTS focuses on providing family members and carers the knowledge and skills to interact more effectively with their family member with BPD. The sessions are structured and semi-manualised and include didactic psychoeducation, group discussions, in-session practice of skills and homework tasks to practice between sessions. The program was designed to be delivered by family members or carers with lived experience of caring for a person with a diagnosis of BPD. At Alfred CYMHS the program will be facilitated by both a carer support consultant with lived experience of caring for a family member with BPD, and a trained mental health clinician. The program is designed to provide families and carers the skills to understand and interact with their person with BPD differently. The project will evaluate the impact of the program on the experience of adverse events by family members and carers in relation to the person with BPD, and the wellbeing, depression, anxiety, stress, family functioning, and experience of burden outcomes for the family members and carers participating. The project will also evaluate the impact of the program on the experience of family functioning as reported by the person with Borderline Personality Disorder via survey, and also their broader experience and perception of having their person complete the MBT-FACTS program which will be gathered via focus group. The project will utilise a delayed-treatment Randomised Control Trial (RCT) design, with half of the referred families and carers allocated randomly to commence in the first treatment group, and the other half allocated to commence the program approximately 3months after the commencement of the first group. The young person with Borderline Personality Disorder will continue to receive treatment as usual regardless of the randomisation group of their family member or carer. Any usual supports available to the carer of family member will also remain available.

  • A study that examines the feasibility of establishing a database that examines how genes affect opioid drug response in palliative care patients

    Pain occurs in about 60% of people with advanced cancer. Currently, there is no method of predicting which opioid pain medication works best for each person, nor predicting who will develop side effects from which medication. This project will determine if it is feasible to collect clinical, biological and genetic data, in order to provide a personalised method of achieving optimal pain control. Who is it for? You may be eligible for this study if you are an adult with pain related to cancer. Study details All participants in this study will be seen twice in addition to their usual care – once at the enrolment into the study and once 7 days later. On these days participants will be asked for clinical information and to complete some questionnaires about their symptoms (questions about pain relief, side effects and levels of function) and given questionnaires to complete regarding their. A blood test will also be taken during this time, which includes samples for opioid levels in the blood, markers of inflammation and genetic markers. It is hoped that this research will determine whether it is possible to provide more personalised pain relief based on a patient’s clinical, biological and genetic information.

  • A prospective study conducted in an adult intensive care unit to measure the breakdown products of citrate during kidney dialysis

    The primary aim of the study is to quantify to plasma concentration of citrate metabolites (eg: triglycerides) when using RCA with CRRT. We expect to establish a means and standard deviations for these plasma concentrations. Our secondary aim is to track the concentration of citrate over time.

  • Does the use of oxytocin in a pulsatile fashion (intermittent boluses), when compared to the use of continuous oxytocin, for the commencement and/or assistance of labour, result in a reduction in the number of caesarean sections that are required?

    In 2017, at The Northern Hospital, one in three women required an induction (commencement) and/or augmentation (assistance) of their labour. Induction and/or augmentation is initiated with a medication called oxytocin that is given to you intravenously via a cannula (drip) that is placed on one of the veins on the back of your hand. Oxytocin may be given continuously, or it may be given in a pulsatile fashion (small amounts of the same medicine every 15 minutes). We believe that oxytocin given in a pulsatile fashion is more physiologically normal, which might reduce the incidence of emergency (unplanned caesarean sections) as well as reduce the frequency and severity of post partum haemorrhage (bleeding post the delivery of your baby).

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