ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Dietary fat, airway inflammation and bronchodilator response in asthma - Study 2

    This study will investigate the mechanisms by which nutrient surplus heightens inflammatory responses and interferes with pharmacological management of asthma. Our previous work demonstrates that in asthma, consumption of a high energy mixed meal activates innate immune responses in the airways, with increased TLR4 expression and airway neutrophilia. The specific nutrient responsible for this effect is uncertain; therefore, we will assess the independent effects of saturated fat, omega-6 fat and carbohydrate. We have also observed that a high energy mixed meal leads to impaired bronchodilator responses; therefore, the effect of each of these nutrients on bronchodilator response will also be investigated. Understanding this process is vital, and highly relevant to asthma management, as effective bronchodilator response is essential for achieving good asthma control and providing bronchodilation during acute exacerbations of asthma.

  • A pilot study to evaluate an intensive upper limb rehabilitation program after stroke

    This project aims to develop and test the feasibility of a client­centred intervention for improving dexterity for people with stroke. Upper limb hemiplegia is common after stroke, and such people typically achieve lower levels of functional recovery. Many individuals suffering from hemiplegia after stroke exhibit some shoulder and elbow movement but little or no hand function, preventing them from participating in Constraint­ Induced Movement Therapy (CIMT). Using newer technologies such as a mechanical orthoses offers promise for stroke survivors with hemiplegia. However, no direct evidence exists for optimum wearing regimes, training protocols and timing of therapy. This study will therefore make a significant contribution to healthcare decision making. Participants in the 'treatment' group will be recruited from the Prince of wales in­patient hospital service and will receive an 8­-week intervention which will include intensive one­-on­-one movement training sessions, behavioural strategies to increase patient motivation, and a task ­specific home exercise program using a hand splint. Participants in the 'control group' will be recruited from the same centre and will receive usual rehabilitation. Outcomes will be assessed at baseline, post­ intervention, and at 3 months following the conclusion of intervention and will include assessment of range of movement, dexterity, functional task performance, and quality of life.

  • Does outpatient physical rehabilitation improve or maintain functional independence for people with Friedreich ataxia?

    Friedreich Ataxia is a degenerative disease impacting on the ability to mobilise and reducing independence in daily activities. This study aims to determine if outpatient rehabilitation improves or maintains functional ability and quality of life, as compared to a wait-list control. People attending a specialist multidisciplinary Friedreich ataxia clinic and who would benefit from rehabilitation, will be invited by the clinic to participate in this study. Consent will be gained at the Kingston Centre Participants appropriate for outpatient rehabilitation will be randomised into an intervention group or a control group, using a computer program. Intervention will be ‘accelerated’ standard-care, rehabilitation including physiotherapy, aquatic physiotherapy and exercises, and the wait-list period of the program will generate the control group. The duration of rehabilitation will be 6 weeks, and rehabilitation will be provided three times per week. A home exercise program will provided for participants in both groups to complete for six weeks following the rehabilitation program. Outcome measures will examine quality of life, disease progression, performance of daily life activities, mobility and spasticity. These measures will be taken at baseline, pre and post-rehabilitation, and six weeks following rehabilitation.

  • Effect of application of Transcutaneous Electrical Nerve Stimulation (TENS) on acupunture points (Acu-TENS) compared to Sham-TENS on breathlessness and exercise capacity in people with chronic obstructive pulmonary disease (COPD)

    Participants with COPD usually complain of dyspnoea during exercise which limits their exercise tolerance. Previous studies have shown that one session of Acu-TENS could alleviate breathlessness in participants with COPD (Lau and Jones, 2008; Ngai et al., 2011). The aim of the study is to evaluate the effect of Acu-TENS compared with Sham-TENS on exercise capacity and breathlessness in people with COPD. People with COPD who meet the inclusion and exclusion criteria will be recruited. After informed consent, each participant will attend for 4 visits. During the first visit, participants will be asked to perform two incremental shuttle walk test (ISWT) for determining the intensity level for the endurance shuttle walk test (ESWT). On the second visit, participants will be asked to perform two ESWTs to ensure accurate measure of endurance exercise capacity. On the third and fourth visit, participants will be randomly assigned to receive either Acu-TENS or Sham-TENS. Randomization sequence will be generated by a randomisation software by an investigator who is not involved in the data collection, and will be concealed in an opaque envelope. Both assessor and the patient will be blinded to the intervention. On visit 3 and 4, participants will perform one ESWT, followed by 45-minute of either Acu-TENS/ Sham-TENS which will be continued during the second ESWT. The change in endurance shuttle walk test time on visit 3 and 4 will be the primary outcome measure. Secondary outcome measures will be level of dyspnoea at isotime and distance walked in endurance shuttle walk test. The findings of the study will elucidate whether Acu-TENS will improve endurance exercise capacity and reduce breathlessness, thus, enabling people with COPD to improve functional capacity.

  • Effect of Sulforaphane on the Vascular Status and Oxidative status of Type 2 Diabetes

    The prevalence of Type 2 diabetes and its complications is increasing globally. The condition is associated with lifestyle factors which impact biochemically at many levels. Markers of oxidative stress are typically elevated in the diabetic condition but attempts to regulate oxidative stress with antioxidant vitamins have been generally unsuccessful. The plant-derived capsules to be used in this trial yield a phytochemical, sulforaphane which has been shown to activate pathways leading to elevation of the cell's endogenous antioxidant enzymes and other cytoprotective compounds such as glutathione. This trial is aimed at testing the efficacy of such capsules in modifying the disease parameters associated with Type 2 diabetes.

  • Dynamic changes in clot formation using Thromboelastometry after reinfusion of unwashed cell salvaged whole blood in total hip arthroplasty: a pilot study

    A pilot study: As part of our standard care, in line with a comprehensive blood management approach, patients presenting for primary hip arthroplasty are offered intra-operative cell salvage. One type of cell saver used is the SANGVIA system. Blood is collected during surgery, filtered and can be reinfused post-operatively. This is a relatively new technology and there is some controversy around the efficacy, safety and potential adverse effects of the reinfusion. This includes some concern whether a coagulopathy might be induced by reinfusion through various mechamisms. of cytokines. A "point of care device" "ROTEM" is well established in clinical medicine. It is comprehensive diagnostic system coagulation management. We would like to assess the patients' clotting profile before incision and the potential impact of reinfusion of the salvaged blood at the end of the operation. This will be conducted with ROTEM , testing for ex-TEM S (screening extrinsic clotting pathway & platelet contribution to clot formation), in-TEM S (screening intrinsic clotting pathway & platelet contribution to clot formation)compared to standard Lab testing (INR, aPTT). A small sample volume of the shed blood is collected and analyed for haemoglobin and platelets to assess the quality and composition of the blood. In addition a 2nd sample is frozen which will be analyzed after completion of the study to assess the presence and levels of imflammatory mediators.

  • Therapeutic hypercapnia after cardiac arrest: a pilot feasibility and safety randomized controlled trial

    Cardiac arrest is a relatively common and devastating event in Australia and New Zealand (ANZ). It is associated with extremely high mortality. A large proportion of those who survive are left with serious neurological disability. Such disability includes memory loss, paralysis and difficulty in thinking and speaking. These deficits often lead to a loss of independence and the need to be admitted to aged-care facilities. Immediate cardio-pulmonary resuscitation and defibrillation by bystanders has only partly improved the outcome of these patients. For those who survive the immediate phase and are admitted to the intensive care unit, actively decreasing the body temperature to 33-34 degrees C has been shown to protect the brain. Although limited, these results suggest that some interventions after cardiac arrest can improve brain outcome. Perhaps other interventions could lead to similar results and further improve patient’s recovery and quality of life after cardiac arrest. In a recent observational study in 12,000 ANZ patients who were admitted in ICU after a cardiac arrest, we found that those who had an elevated partial pressure of carbon dioxide (PaCO2) in the 24 hours following the cardiac arrest had a higher chance of having a satisfactory neurological recovery. These patients were 20% more likely to be able to go back home at the end of their hospital stay as compared with those whose PaCO2 was either in the normal or low range. These findings are similar to those seen in previous animal studies. They also make physiological sense: a higher PaCO2 is known to trigger an increase in the amount of blood directed towards the brain. An increase in brain blood flow after a cardiac arrest (a state of no flow) should be logically associated with a higher chance of recovery. However, these findings need to be confirmed by prospective trials before they can be applied to all patients with a cardiac arrest. PaCO2 is normally controlled by the lungs and its arterial partial pressure is directly related to the rate and amplitude of the breathing process. After a cardiac arrest, patients typically are unconscious or heavily sedated by medication and their breathing process is almost entirely taken care of by a ventilator (breathing machine). In such circumstances, the PaCO2 is determined by the medical team. Currently, a “normal” value for PaCO2 (35-45 mmHg) is targeted by clinicians. However, changing this target value to 50-55 mmHg, would be technically easy to implement and carry no extra cost. Based on the findings of our retrospective study (Schneider et al, Resuscitation 2013), on animal studies and logic, we hypothesize that a higher PaCO2 in the first 24 hours after cardiac arrest will be associated with less neurological injury and be feasible and safe. To test this hypothesis, we plan to randomly allocate 75 patients admitted to ICU after cardiac arrest to either “High PaCO2” or “Control” group. The pan to enrol 75 participants is purposeful. This approahc willl provide the means to obtain a complete set of brain biomarker samples (those being baseline, 24 hour, 36 hour and 72 hour) for a total of 50 participants. The key outcomes of interest would be whether such trial can be done, whether this therapy appears safe and whether it decreases blood test-based markers of brain injury (brain proteins like neuron specific enolase and S100 protein), indicating that a biological benefit is taking place.

  • A randomised trial of quality of recovery in ambulatory surgical patients receiving general anaesthesia versus regional anaesthesia

    Ambulatory surgery is performed as an outpatient day-only procedure, and is considered minor surgery. Anaesthesia for this type of surgery can be with general anaesthesia (GA) only, or GA in combination with regional anaesthesia (RA). However, while it is assumed that outpatient surgery constitutes minor surgical stress, there are sufficient case series observing severe cognitive dysfunction and poorer than expected functional recovery even after brief surgery. Anaesthetists have used RA techniques on the assumption that an effective nerve block allows a reduction in GA doses, better and prolonged analgesia, and a positive influence on post-operative recovery. This study will help anaesthetists determine if anaesthetic choices will lead to better outcomes for their patients undergoing minor ambulatory surgery. The primary endpoint of this study is the incidence of cognitive recovery at day 3 between groups. Secondary endpoints will be recovery in other domains, over time.

  • The effect of consuming a meal consisting of potato or sweetpotato on the feelings of hunger/ fullness and health related blood measurements

  • Energy balance and body composition in young children with cerebral palsy

    This research project aimed to investigate aspects of energy requirements, energy intake and body composition in a population of preschool aged children with cerebral palsy. Results and outcomes will help inform clinical practice for this population and direct future research.

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