ANZCTR search results

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

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32121 results sorted by trial registration date.
  • 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

  • Distinguishing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis in Adults: the Role Esopahegal Mucosal Immunoglobulin IG4

    Background: Eosinophilic esophagitis (EoE) and gastroesophageal reflux disease (GERD) can be difficult to distinguish as many of their clinical and histological features overlap. Preliminary data suggests a potential association between EoE and immunoglobulin G4 (IgG4), but not GERD. Aim: To examine the role of esophageal mucosal IgG4 staining in differentiating EoE from GERD. Methods: Esophageal biopsy specimens from patients with proven EoE and GERD were evaluated and immunohistochemical staining for IgG4 was performed by an experienced gastrointestinal pathologist blinded from the clinical and endoscopic data. The results on IgG4 staining was then correlated with clinical, endoscopic and histological features.

  • Stomach distension with high flow nasal oxygen therapy. A volunteer study

    High flow nasal cannula (HFNC) has been shown to provide better oxygenation compared to the venturi face mask and low flow nasal cannula during intravenous sedation for both bronchoscopy and dental procedures . Though there are no major effects reported with this device, gastric distension is a theoretical possibility. Continuous high flow together with the ability to create low levels of positive airway pressure can potentiate gastric distension. When gastric distension occurs, it causes an increase in the secretion of gastric acid through vagal response. Hence, there is a potential for increased gastric volume and secretions, along with an elevated intraluminal pressure. This may increase the risk of pulmonary aspiration of gastric contents. Data is lacking as to quantify this issue in clinical practice. The aim of this study is to assess gastric insufflation and volume in healthy volunteers after application of HFNC. We hypothesise that the application of high flow nasal oxygen will not result in gastric distension. Measurements will be made of the incidence of gastric insufflation before and after the application of HFNC. When the participants are ready, a baseline ultrasound estimate of the stomach volume estimate is done. Thereafter, oxygen will be delivered through a high-flow nasal cannula. This will be accomplished using the Optiflow THRIVE device (Opti-Flow, Auckland, New Zealand). Flow rate through the cannula will be commenced at 30 L/min and fractional inspired oxygen concentration will be set at 100%. The flow will be gradually increased and maintained at 60-70L/min during the study. The flow rate could be decreased up to 30 L/min if higher flow rate is not tolerated. A set of ultrasound measurements looking for gastric distension and antral area will be made at 10 minutes intervals till 30 minutes of HFNC delivery. Measurements will be obtained between peristaltic contractions when the stomach is resting. A set of three measurements will be made for each outcome variable and the mean value would be recorded. The HFNC will be ceased at 30 minutes and the participants are allowed to rest for another 30 minutes. During this time, they are not allowed to eat or drink. Another set of scans and measurements will be obtained 30 minutes after ceasing HFNC.

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