ANZCTR search results

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

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32814 results sorted by trial registration date.
  • Rocker sole footwear for the treatment of painful midfoot osteoarthritis: a pilot randomised controlled trial

    Osteoarthritis (OA) of the midfoot is a painful and disabling condition affecting 1 in 8 people aged over 50 years. Despite the high prevalence and burden of midfoot OA, there is very little evidence to guide the non-surgical management of this condition. Rocker sole shoes are a type of footwear designed to ‘offload’ the painful midfoot and despite anecdotal evidence to support their use in clinical practice, their efficacy has not been thoroughly investigated. Our multidisciplinary team will conduct a pilot randomised controlled trial (RCT) to gather information on feasibility and investigate the potential benefits of rocker sole footwear for painful midfoot OA, which is necessary to plan a rigorous RCT. Adults with painful midfoot OA (n=30) will be randomly allocated to receive either a pair of rocker sole footwear or standard footwear for 12 weeks. This study will assess key outcomes relating to trial feasibility (primary outcomes: recruitment, intervention use and adverse events) and if the footwear affects pain levels, foot-related disability and midfoot joint structure on MRI.

  • The utility non-mydriatic fundus photography in a regional Australian emergency department

    Fundoscopy (looking at the back of the eye) is extremely valuable but rarely done as the traditional direct ophthalmoscope is hard to use. The consequence is delay to diagnosis or missed diagnosis of potentially critical eye and whole body conditions. Digital fundus photography has been demonstrated as a superior alternative to direct ophthalmoscopy, detecting problems amongst 10-18% of relevant emergency department (ED) patients in metropolitan hospitals. We aim to determine how often fundus photography improves the management of patients, and the prevalence of fundus pathology in a regional setting. We hypothesise that fundus photography will: 1. change the management of patients in the ED; 2. be more accurate in diagnosis than direct ophthalmoscopy; 3. detect a rate of pathology similar to that found in metropolitan EDs.

  • A study assessing the impact of frailty on therapy in older people with blood cancers

    This study is looking at how changes associated with ageing or frailty in people aged 65 years and older impacts on their ability to tolerate treatment for their blood cancer and how the therapy affects their fitness and quality of life. Who is it for? You may be eligible for this study if you are 65 years or older and you have been diagnosed with one of the following conditions: Myelodysplastic syndrome (MDS), Acute myeloid leukemia (AML), Multiple myeloma (MM), Diffuse-B cell Lymphoma (DLBCL), and will commence treatment either for the first time or after a first relapse. Study details All participants will undergo frailty screening assessments to determine eligibility to stream 1 (standard of care) or stream 2 (randomization to Arm A or Arm B). Participants will be allocated to stream 2 if they have two or more screening assessments with scores outside the normal range. Stream 1 participants will have one or no scores outside the normal range. All participants in stream 2 will be randomly allocated (50/50 chance) to Arm A or Arm B. Participants in Arm A will receive standard care from their Haematologist. Participants in Arm B will receive a tailored multidisciplinary approach to their management with specialists including a Geriatrician, Physicians, nurses, allied health and pharmacists. This visit with the specialist will take up to 1 hour for a comprehensive review. Participants in Part B will also be followed up monthly via phone calls. All participants regardless of allocation with be provided with a diary to log GP visits, emergency room encounters, unplanned admissions and any other event of significance to you. Why is this important? The knowledge gained from this trial will help doctors to determine the best therapy option for an individual by taking into consideration their unique ageing process and quality of life prior to commencing therapy. This will provide a more tailored approach to managing an older person's cancer.

  • The effect of Complex Milk Lipids on cognitive ageing

    The aim of the present study is to investigate the effects of Complex Milk Lipids on cognitive function and other health-related outcomes—including physical health, psychological wellbeing and blood biomarkers—in ageing adults 55-to-75 years of age. Ingredients developed by the principal trial sponsor contain higher levels of milk phospholipids and gangliosides (complex lipids) and may have the potential to produce benefits on these outcomes. This will be a 16-week randomised, double-blind placebo-controlled trial where 300 participants will be recruited across the CSIRO and Swinburne University sites. The trial will consist of three intervention arms: 1) Low dose milk drink delivering ~10g of total CMLs; 2) High dose milk drink delivering 25g of total CMLs; and 3) Rice starch placebo control

  • Does utilisation of surgical humidification reduce surgical site infection in colorectal surgery patients? A randomised control trial

    Research Aims To assess the efficacy of warm humidified carbon dioxide (CO2) insufflation to reduce surgical site infection in patients undergoing open colorectal surgery. Participants Adult participants undergoing open colorectal surgery at Dandenong Hospital who meet the inclusion and exclusion criteria. Methods Eligible participants will be randomised to receive standard of care or standard of care plus warm humidified carbon dioxide insufflation of the open wound during their scheduled open colorectal procedure. Insufflation will be provided with the HumiGard Surgical Humidification system, up to 10L of CO2 gas will be slowly insufflated into the surgical cavity for the duration of the operation. Participants will be blinded to their allocation. Expected outcomes Completing this project will allow us to determine whether warmed and humidified carbon dioxide gas can assist with reducing surgical site infections.

  • The effects of the education program and other factors on the number of sedative medications that older people with dementia regularly consume.

    The aims of this study are as follows: 1. To determine whether an education program directed at nurses, pharmacists and professional care staff will reduce the use of sedative medications in older people with dementia living in Residential Aged Care Facilities (RACF). 2. To determine the effects of the education program and other factors on the number of sedative medications that older people with dementia regularly consume. This project is aimed to reduce the use of antipsychotics and benzodiazepines among residents with dementia through the education program. These medications were associated with a significant increase in adverse events and an increased risk of mortality. Previous studies have suggested that these medications can also affect the cognitive state among older adults with dementia. Benzodiazepine use has been associated with accelerated cognitive decline and limited benefits. Antipsychotic medications have also been associated with considerable cognitive adverse effects in people with dementia. Degeneration of cognitive function and mood often reduces quality of life amongst people living with dementia. Therefore, it is important to investigate the effect of these medications on cognitive state and the quality of life of dementia residents .

  • Management of paediatric donor sites of split-thickness skin grafts with Suprathel: a randomised control trial

    Split-thickness skin grafts are routinely used to manage burns that are unlikely to heal with dressings alone. The skin graft is taken from a donor site, for example the thigh, creating a donor site wound. Treatment of this donor site wound has an impact on the total recovery and rehabilitation of the patient. Multiple dressings have been investigated for the management of the donor site wounds, including biobrane, calcium alginate, acetate guaze and gauze mesh. However, despite previous research the optimum dressing for donor site wounds remains unclear. Suprathel is an artificial substitute skin dressing that is commonly used on burns and graft site wounds. The paediatric surgeons at The Townsville Hospital have observed that Suprathel also has positive results when used on the donor site wound. Therefore, we propose to investigate the management of paediatric donor site wounds of split-thickness skin grafts with Suprathel in a randomised controlled study. We plan to compare the use of Suprathel with jelonet, a commonly used dressing on the donor site. Participants: Children 16 years or under requiring a clinically indicated split thickness skin graft Expected outcomes: Identifying whether Suprathel is superior to a commonly used dressing on paediatric donor sites.

  • A pilot gender-sensitised lifestyle intervention for overweight men targeted at physical activity, diet, and mental health

    Physical activity, diet, and mental health practices play an important role in chronic disease prevention and management. Underrepresentation of men in healthy lifestyle programs tells us that more can be done to engage men and support them in making healthy lifestyle changes. The aim of this study is to develop and test a lifestyle intervention for men living in Australia aimed at improving the physical activity, diet, and mental health of those at an increased risk of chronic disease (i.e., overweight weight, inactive, insufficient fruit and vegetable consumption). We believe that men in the HAT TRICK intervention group will show greater improvements in a) physical activity, b) diet quality, c) risk of depression scores, d) physical fitness, and e) anthropometrics at 3 months post-baseline, compared to a wait-list control group.

  • A pilot randomised waitlist-controlled study investigating a psychosocial life skills program called Thrive, for young adults 18 to 25 years with chronic illness.

    This study will evaluate the effectiveness of a psychosocial life skills program by measuring improvements in quality of life (standard of health, comfort and happiness), social connectedness (the relationship people have with others), and perceived stress (the degree to which situations are seen as stressful). Participants will be randomised into one of two groups; the intervention (being the Thrive program attendees who consent to take part in the study) or the waitlist-control (people waiting to be enrolled in a Thrive program).

  • A Healthy Volunteer Study Evaluating the Tolerability and Pharmacokinetics of PRN473 Topical

    The purpose of this research study is to assess the safety and tolerability of PRN473 Topical as well as the pharmacokinetics (PK - how your body absorbs medications). We are doing this study in healthy men and women to find out: • Does the drug have any side-effects and is it well tolerated when given topically as a single dose and in multiple doses? • How much of the drug when given topically gets into the blood stream, and how long does the body take to get rid of it? This study will compare PRN473 Topical with placebo. A placebo has no active drug in it. One group of participants will receive PRN473 Topical and another group will receive the topical placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive the placebo. This study will look at how participants react to, and how the human body uses PRN473 Topical at different dose levels. In total there are planned to be 2 parts to the study. Part A will look at the effects of a single topical dose of the study drug and Part B will look at the effects of multiple topical doses of the study drug

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