ANZCTR search results

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

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31350 results sorted by trial registration date.
  • Assessment of heart function with positron emission tomography (PET) imaging: comparison to conventional cardiac gated blood pool scanning

    The study is comparing two techniques to assess heart function in patients referred to the Peter MacCallum Cancer Institute. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been referred to the Peter MacCallum Cancer Institute for assessment of heart function. Why might this test be needed? A "cardiac gated blood pool scan" (CGBS) is a commonly requested to scan to identify problems with your heart function. Impaired heart function can be a serious adverse effect of chemotherapy and other new anti-tumour agents. Depending on the type of treatment you are receiving, it is therefore important to identify any damage to the heart following treatment or to check heart function before starting treatment. If damage is found, the dose of your treatment may be reduced or a different type of treatment may be chosen. How is the standard test performed? The conventional test is a nuclear medicine imaging test which involves labelling blood with a radioactive substance, and then measuring the amount of blood in the heart during different parts of the heart beat. A special camera, called a gamma camera, measures activity in the heart which is matched (also called “gated”) to your heart rhythm. This test is called a “cardiac gated blood pool scan” (CGBS). The amount of blood being pumped out of your heart, called the left ventricular ejection fraction (LVEF), can then be measured. How is the new test for this study performed? The new test is performed by labelling your blood with a different radioactive substance, called gallium-68. This enables images to be obtained on a newer type of camera, called a positron emission tomography (PET) scanner. What are the potential advantages of this new test? The PET scanner produces three-dimensional (3D) images of higher quality and in a shorter amount of time than the conventional test. How might this study contribute to patient care? The knowledge acquired from this study will be used to validate this new test. If we can demonstrate that it is at least as good or better than current technology, it may replace the existing test in the future. Trial details. This study aims to recruit 40 patients. Both the conventional and new CGBS will be performed in each patient, and the results compared. The new test involves an additional scan performed in a positron emission tomography (PET) scanner. Images of you heart will be performed for 5-10 minutes after being positioned on the bed of the PET scanner. The new scan will be performed shortly after the conventional scan.

  • The Effect of Zinc Supplementation on Expression of Zinc Transporters in Healthy Individuals

    Sub-groups of the Australian population are considered at risk of zinc deficiency but uncertainty remains in the interpretation of zinc biomarkers. Zinc has no definable, accessible body stores. Our proposal aims to explore the usefulness of zinc transporters, which regulate the movement of zinc into and within-cells, as potential biomarkers of zinc status in humans. We aim to examine the feasibility of using peripheral blood mononuclear cells for the assessment of zinc status. If our approach is successful we will have the potential of investigating zinc status in greater detail.

  • Online treatment for depression in people with diabetes: a randomised controlled trial

    The aims of the current study are to evaluate the efficacy of a validated internet-based cognitive behavioural therapy (iCBT) program (CRUfAD's Sadness Program) for depression when delivered to individuals who meet criteria for a major depressive episode comorbid with Type 1 or Type 2 diabetes. This study will recruit 100 people with depression and diabetes and randomly allocate them to 1 of 2 conditions: Diabetes treatment as usual (TAU) + iCBT for depression or Diabetes TAU + delayed iCBT for depression (TAU waitlist control). The primary outcomes will be to determine the impact of online CBT for MDD on depression symptoms and remission rates, as well as on diabetes-specific outcomes. We will also measure adherence to the course material and satisfaction with the intervention generally.

  • The effect of group work-circuit and individualised physiotherapy treatments for orthopaedic patients: a randomised control trial

    Question: Is group work-circuit physiotherapy an effective model for orthopaedic rehabilitation or is individual therapy more beneficial? Design: Randomised control trial, single-blinded. Participants: Twenty-one in-patients with an orthopaedic problem participated in rehabilitation at John Flynn Private Hospital, Tugun, Queensland. Intervention: All participants received physiotherapy twice daily, six days a week for a variable period (one to three weeks) depending on length of stay (LOS). Each participant had an individualised physiotherapy session in the morning for 30 minutes and then were randomly allocated a further 30 minutes of individualised treatment (Group A) or participated in a group work-circuit physiotherapy program (Group B) in the afternoon. Outcome measures: Measures were undertaken at admission/discharge for all patients admitted to the study. Demographics (age, gender, condition, LOS), pain level (Visual Analogue Scale) and the ability to straight leg raise (able/unable) were recorded. Balance and mobility measures included: the Berg Balance Scale, the Modified Elderly Mobility Scale, the 10 metre walk test and the Timed Up and Go test. Results: This pilot study demonstrated that both the individual and group work-circuit interventions are effective treatment options for a mixed group of orthopaedic patients. Participants in individual and group work-circuit interventions improved in all balance and mobility outcome measures (p<0.05), but only the work-circuit group reported less pain (p<0.05). Conclusion: These preliminary results show that both intervention and models are effective for the rehabilitation of people with orthopaedic problems. These results indicated that group work-circuit therapy is a cost-effective model for orthopaedic rehabilitation.

  • A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin vs. Placebo in Cardiac Surgery Patients with the Post-operative High Cardiac Output and Hypotension syndrome

    The management of patients who have a high cardiac output (the amount of blood pumped by the heart every minute) and a low blood pressure after open heart surgery is complex because the best way to deliver best post-operative treatment of the circulation is uncertain. However, treatment typically includes the use of fluids given though a vein and drugs to help increase blood pressure to safer levels. Such blood pressure drugs can be useful but can have adverse effects on heart function or cause disturbances of the heart rhythm. Thus, they are often avoided and used very late in the management of these patients when blood pressure is really low. As a consequence, blood pressure may remain undesirably low for a long time and patients may be given large amounts of fluids instead, which can also be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients who have a high cardiac output with low blood pressure and worsening kidney function. Terlipressin can be given as a single shot through any hand or arm vein and can increase blood pressure for up to 6 hours. Terlipressin offers the opportunity to improve blood pressure management in patients with a high cardiac output and a low blood pressure after heart surgery without the risk of causing heart injury and rhythm disturbances. However, because terlipressin has only been used to support blood pressure in this way in liver patients, we do not know how effective it would be in such selected cardiac surgery patients. In this study we wish to test whether, in open heart surgery patients with a high cardiac output but a low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment is safe and changes the amount of fluid given and kidney function for the better.

  • Attitudes and beliefs of dietary intake and health risks in people with type 1 & type 2 diabetes

    To investigate in a cohort of people with type 1 and type 2 diabetes: - The knowledge of the health risks associated with dietary intake - Ability to interpret the nutrition information on Australian food labels - The frequency of use of nutrition labelling on food products - The influence nutrition panels has on shopping behaviour - Urinary electrolyte excretion and the association this has with dietary intake - Usual dietary intake - Body mass index and HbA1c in association with the above information

  • A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin versus Placebo in Hypotensive Sepsis

    The management of patients who have serious infection and a low blood pressure is complex and includes making sure that the circulation is stable, safe and optimal in terms of blood flow to vital organs. This is called resuscitation. The best way to deliver resuscitation is uncertain. However, it typically includes the use of fluids given though a vein and drugs to help increase blood pressure. Drugs to increase blood pressure can be useful but those available either have a short duration of action (minutes) or can only be given though a large vein. As the need for drugs to increase blood pressure can last for hours or even days, this means that a special catheter needs to be inserted for such treatment into a large central vein like the jugular (neck) vein. This carries risks, requires special expertise and takes time. Thus, potentially helpful treatment is often delayed. As a consequence, blood pressure may remain undesirably low for more than an hour and/or the patient may be given large amounts of fluids instead, which can be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients with low blood pressure and worsening kidney function. Terlipressin can be given as a single dose injection through any hand or arm vein and can increase blood pressure for up to 6 hours. Terlipressin offers the opportunity to improve blood pressure management in patients with serious infection. However, because terlipressin has only been used to support blood pressure in this way in liver patients, we do not know how effective it would be in patients with infection. In this study we aim to test whether, in patients with infection and low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment changes the amount of fluid given and kidney function.

  • A comparison of different endoscopic modalities for the detection of dysplasia and early cancer in patients with Barrett's Oesophagus undergoing surveillance endoscopy.

    This project will examine the utility of a novel endoscopic imaging device (Narrow Band Imaging – NBI) and compare this technology against the present standard of care in patients with a chronic premalignant condition known as Barrett's Oesophagus. Who is it for? You may be eligible to join this study if you are aged between 18-85 years and are scheduled to undergo surveillance endoscopy for Barrett’s Oesophagus (BE), or have been referred for further assessment of dysplasia/early cancer in BE. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care, which consists of white light endoscopy (WLE) and random biopsies followed by examination with NBI and NBI and dual focus magnification (NBI-DF). Participants in the other group, will receive an examination with NBI and with NBI-DF in addition to standard care. NBI and NBI-DF are endoscopic imaging technologies which can be utilized with a switch of a button on the endoscope. Images can then be obtained which may enable better visualization of the Barrett’s segment. These are non invasive technologies where the light at the end of the endoscope changes to a more ‘narrow wave length light’ which could improve visualization of vasculature which can be more pronounced in early neoplasia. Targeted and random biopsies will then be taken. Endoscopy results will be compared to histology to determine whether NBI and NBI-DF can improve the detection of precursors of cancer or early cancer which may enable earlier and less invasive interventions for these patients. All patients will receive the same treatments,but in a random order.

  • Infectivity of the Plasmodium falciparum 7G8 malaria cell bank, MCB-004, in humans.

    This study is examining the infectivity of a Plasmodium falciparum 7G8 malaria cell bank in humans. Participants will receive a single inoculum of the malaria cell bank, which consists of human red blood cells containing P. falciparum 7G8 malaria parasites. Followng administration of the inoculum, we will measure the growth of the malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) according to specific criteria (based on the number of parasites in the blood as well as clinical signs/symptoms of malaria). We will also be assessing the safety of the inoculum and also the way the immune system responds to it. Determining the infectivity and safety of the malaria cell bank is important as it will form a critical part of future clinical trials investigating the effectiveness of a new malaria vaccine that is currently being developed.

  • Go Nuts! - Including non-allergic nuts in the diet of children with nut allergy

    Children who have nut allergies must avoid that nut in their diet, but this can be difficult to achieve. Young children may be unable to tell different nuts apart due to similarities in appearance. Nuts can also be present in baked goods, dips, muesli bars and other foods, requiring reading of the label. Some children are also allergic to more than one nut adding complexity to this process. Having a child who is allergic to nuts can also cause anxiety around social events such as parties and school camps and can have a significant impact on quality of life of both the parents and child. Due to the difficult nature of avoiding one type of nut, in the past it has been common for parents to avoid all nuts, either on advice of their doctor, or for their own peace of mind. More recently however, it appears that there may be benefits from having ongoing exposure to non-allergic nuts in our diets. Totally avoiding nuts we are not allergic to may increase the risk of developing an allergy to this nut later on. Parents of children with nut allergy are now being advised to include non-allergic nuts in their child’s diet on an ongoing basis. To ingest the suggested amount of nut as often as required can be difficult. In this study, we will provide to the intervention group, a resource which aims to help parents achieve this. It contains a series of recipes and suggestions for including nuts in every day foods to provide an alternative to eating whole nuts. This group will also receive monthly text messages reminding them to include non-allergic nuts in the diet. We also hope that this will increase knowledge surrounding the intake of nuts, reduce anxiety and help to improve quality of life for these families.

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