ANZCTR search results

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

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32882 results sorted by trial registration date.
  • Postprandial effects of white meat versus red meat consumption on blood lipids.

    Fatty acids are a necessary key energy source in the body, however, when present in excess, can be detrimental. Increased fasting blood fat (lipid) levels have long been accepted as a risk marker for chronic diseases such as cardiovascular disease, metabolic syndrome, obesity and diabetes, however, there is now increasing evidence which points to postprandial lipemia being a more accurate indicator of risk. The rate in which fats from the foods we consume are digested, absorbed and appear in the bloodstream is dependent on various factors, including (but not limited to) the quality and quantity of fat and the nature of the matrix in which fat is embedded in the food. Postprandial monitoring of lipids therefore can reveal the variable response to food intake not seen under fasting conditions. It is this variation which is referred to as the Lipemic Load. Analysis of the Lipemic Load provides a simple and accurate means of predicting the ability of a food in modulating blood lipid levels, and can be used as a tool to help consumers choose foods for optimal health.

  • The Which Heart failure Intervention is most Cost-effective in reducing Hospital stay (WHICH? II) trial.

    Chronic heart failure is one of the leading causes of death and disability within our ageing population. Chronic heart failure management programs now form part of the gold-standard care for patients hospitalised with the syndrome to prevent costly recurrent readmissions and prolong survival. However, there is still a need to apply these cost-effectively - particularly in respect to meeting the needs of high risk individuals and those living remotely to a heart failure service. Following on from the original WHICH? Trial we are now testing two different ways of applying chronic heart failure management to determine which is most cost-effective in reducing recurrent hospital stay. Specifically, we are testing a more intensive program of care, based on each person’s needs and where they live, with a standard program of care and support. We will compare the impact of standard care in the community (Group 1) with more intensive care in the community (Group 2). Health outcomes will be compared at 12 months with plans for more prolonged follow-up to 5 years post index hospital discharge.

  • A pilot study on function and symptom changes with the use of foot orthoses in the flat footed adult.

    Participants will be required to have measurable flexible pes planus, meet inclusion and exclusion criteria and be willing and able to attend four sessions at the University of South Australia’s biomechanics clinic. Participants will be aware that they will randomly receive either a soft or firm orthoses. Initial assessment: If consent and inclusion criteria are satisfied foot health measures will be undertaken and a practice session of walking tests completed. Casting: Casting of the feet will be undertaken. Randomising of allocation occurs into semi-rigid functional foot orthoses or soft, non-functional insoles. A practice session of walking tests completed. Dispense: Foot health measures undertaken. Inserts are dispensed. Two walking tests completed wearing armband monitor with and without inserts in participants shoes (randomised order) supervised by principal researcher. Walking tests are timed and recorded by an independent and blinded person. Follow up: Foot health measures undertaken, two walking tests completed wearing armband monitor with and without inserts in participants shoes (randomised order) supervised by principal researcher. Walking tests are timed and recorded by an independent and blinded person. Data Analysis: Data will be collated and entered into the computer by an independent person blinded to the allocation. Statistical analyses will determine if measured changes between the insert conditions (functional vs non-functional and shoes vs insert) are significant with a predetermined clinically significant outcome being set at 5% improvement for both energy cost and walking distance changes. Foot health will be reported as a percentage change for pain and fatigue VAS outcomes, the FHSQ will be transformed into an overall foot health score as determined by the protocol for this tool. Statistically analyses will determine if (any) measured changes are significant.

  • A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm Study of the Safety, Tolerability and Pharmacokinetics of Oral BTD-001 in Healthy Volunteers

    This is a randomized, parallel arm, double-blind, placebo-controlled study. Subjects will be randomized to one of 5 arms, 4 dose levels of BTD-001 (25mg, 50mg, 100mg or 200mg) or placebo. Each arm consists of 6 subjects for a total of 30 subjects. Subjects will complete a Screening period of up to 28 days, and will be admitted to the Clinical Research Unit (CRU) on Day -1. First dose will be administered on the morning of Day 1. Plasma samples for PK analyses, vital signs and ECGs will be collected at multiple time points on Days 1 and 2. To allow full PK characterization of the first dose, no evening dose will be administered on Day 1, though dosing will be BID subsequently. Subjects will be discharged on Day 2 with their evening dose of medication and a diary card. Subjects will report to clinic each morning on Days 3-6 for the AM dose of medication. On Days 3, 4 and 5, they will be issued with the evening dose and a diary card. Subjects will be readmitted to the research unit of Day 6 and will receive the evening dose of study drug in the unit, approximately 12 +/- 1 hours prior to the scheduled AM dose for Day 7. Following the AM dose on Day 7, subjects will remain in the CRU for at least 8 hours, during which PK and safety measures will be collected. Subjects will then be discharged home. A final Safety Follow Up visit will take place on Day 14, one week after the last dose of study drug.

  • Assessing support needs of carers in palliative care

    The overall aim of this project is to investigate the extent to which a carer assessment tool of support needs in end of life home care (CSNAT) improves perceived support, carers’ psychological and physical wellbeing, carer burden, bereavement outcomes and the likelihood of the patient achieving their preferred place of death. The CSNAT is a brief tool (14 items on two A5 pages), and is used to elicit carer concerns early, in a systematic way to achieve better outcomes pre and post bereavement. The tool has two sets of items which cover: 1. support that enables the carer to care for the patient at home 2. support for the carer in their caring role

  • Oral Rehydration Solution Orange vs. Apple/Blackcurrant in addition to standard bowel preparation in colonoscopy: a Pilot Study

    This pilot study wishes to investigate whether the consumption of an oral hydration solution (OHS) during bowel preparation will affect the faecal effluent in terms of colour or quality. The investigators will examine whether the endoscopist can detect which colour OHS has been used in conjunction with bowel preparation (if any), and whether the use of an OHS in conjunction with current bowel preparations pre-colonoscopy can reduce the effects of dehydration (ie nausea, dry mouth, headache, lethargy, increased thirst). This may aid in the tolerability of bowel preparation, which in turn may result in better compliance with bowel preparation, with adequate fluid consumption being achieved. The researchers will also investigate whether the inclusion of an OHS has an impact on bowel cleanliness, polyp/adenoma detection, caecal/terminal ileal intubation rate, and time taken to complete the colonoscopy.

  • The PACT Study: Psychosocial Assessment, Care and Treatment of patients with urological and head and neck cancers.

    This study is developing, and evaluating the feasibility, cost and acceptability of, a patient-centred, integrated model of psychosocial care for people receiving treatment for urological or head and neck cancers. Who is it for? You will be eligible to join this study if you are aged 18 years or above and have been diagnosed with a urological cancer or a head and neck cancer, for which you are receiving inpatient and/or outpatient care at John Hunter Hospital. Trial details All participants in this study will receive treatment, as required, under the PACT (Psychosocial Assessment, Care and Treatment) model. As part of this newly developed model of care, all inpatient and outpatient urology and head and neck cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist. This will be used to develop a care plan to address any issues identified through the screening and second-line inquiry. The care plan will facilitate the provision of care which is tailored to the specific needs of patients, and promote continuity of care across care settings and providers; including with health care providers (HCPs) in rural and regional areas. Participants will be asked to report experiences of their cancer care at baseline, and at 21 and 30 months after intervention commencement. It is anticipated that implementation of this model will improve continuity of care, increase health care professionals' awareness, confidence, knowledge and skills to discuss and respond to patients' specific concerns, and improve access to specialised psychological care services.

  • What is the efficacy of therapist-guided and self-guided internet-delivered treatment for young adults (18-24) with symptoms of anxiety and depression?

    This project is part of a research program funded by beyondblue to develop and evaluate Internet based treatment programs for young adults (18-24) with anxiety and depression. This project examines the relative efficacy of guided and self-guided internet delivered treatment. We expect that the guided interventions will result in superior outcomes to the unguided interventions.

  • Taping and exercise for the treatment of exercise related leg pain.

  • Diabetes Prevention Programs Project DP3: Testing the acceptability and effectiveness of different interventions and modalities

    Proposal Aim To compare the effectiveness and cost-effectiveness of several different diabetes prevention programs including face to face groups, phone only interventions and those that use the internet to deliver lifestyle modification programs. Research design Screening, recruitment and referral Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking 40-65 years, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor. Target number of referrals (i.e. participants who are allocated to one of the four programs (see below). IWSML = 200 participants WSML = 200 participants Diabetes Prevention Programs Once eligible participants will be referred to a central point in each ML. The ‘Program Coordinator’ in each ML will contact the eligible participants explain the study, confirm interest and motivation, obtain consent and give them a choice to take up one of the four programs available in each of their ML areas. There will be a slight variation in each ML as follows: Inner West Sydney ML: Get Healthy Service [phone only] Prevent Diabetes Live Life Well [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in PDLLW face to face group program Western Sydney ML: Get Healthy Service [phone only] SHAPE [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in SHAPE program The programs will have to be offered in random order to each participant to avoid a possible bias here. Once the numbers for each arm have been reached then the participant will be told that they only have a choice of what is left. In this research design the PDLLW face-to-face program is the reference group that we will compare the three others to. It has been estimated that a sample size of 100 participants in each arm will be sufficient to detect between 1-1.5kgs weight difference at the 12-month evaluation between groups. The follow up period has been set as short-term evaluation 6-months from entry into the program and medium-term – 12 months from baseline. This allows completion of the intensive intervention 3-month phase and both short-term and medium term effects to be assessed. Evaluation outcomes It is proposed that once participants have been referred and agreed to be in one of the four arms but before they begin one they will be contacted by Computer Assisted Telephone Interviewers from the Boden to assess the main outcomes. Weight/Height Physical Activity Dietary assessment Waist circumference A welcome pack with a letter and tape measure will be sent to participants advising them to have their weight and waist circumference measures ready to report. In addition, sociodemographics and other relevant information will be collected by CATI. Primary outcomes: The primary goals assessed as follows: Weight (self-report) Physical Activity: Active Australia questions at baseline and 12-months collected as part of the CATI. Nutrition: Fat and Fibre index could be measured by CATI or a 3-day non-weighed food diary collected at baseline at the 12-month review. Secondary outcomes: Waist circumference (self-report) General health will be measured using the SF12. CATI to be repeated at 6 and 12 months after baseline.

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