ANZCTR search results

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

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32704 results sorted by trial registration date.
  • An investigation of the effectiveness of prolonged taping of scars to improve their appaerance following surgery

    Several studies have shown that scars on the torso look worse than elsewhere and lead to poor subjective scar satisfaction. We hypothesise that using tapes applied perpendicular across wounds on the torso immediately following surgery and continued for several weeks will result in better looking scars and increased patient satisfaction with the scar.

  • R3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)

    Phase 3 This international trial investigates the use of multi-agent chemotherapy and radiotherapy in children with relapsed or resistant lymphoblastic leukaemia, based on early response as measured by minimal residual disease (MRD) levels, in order to improve treatment. Who is it for? You can join this study if you are aged 1–18 years and have been diagnosed with acute lymphoblastic leukaemia which has relapsed or does not respond to first-line treatment. Trial details Participants are treated with multi-agent chemotherapy and radiotherapy based on early response as measured by minimal residual disease (MRD) levels. (These are the low levels of cancer cells that remain in the body after treatment.) Regular sensitive testing is carried out on the bone marrow to measure how quickly the leukaemia is responding to treatment, and this information is used to help determine whether a transplant or more chemotherapy is a better option for each patient. For those children who show a particularly slow response to chemotherapy, extra intensive chemotherapy is used before transplant to try to improve the control of the leukaemia and improve the chance of cure. Any disease progression is monitored.

  • Psychological Intervention to reduce depression and anxiety in cancer patients undergoing chemotherapy

    This pilot study seeks to obtain preliminary data that addresses the questioon of whether psychological inteventions can improve coping for Cancer patients undergoing chemotherapy for the first time, which is often an uncomfortable process. From a mental health point of view "coping" is operationalised interms of depression, anxiety and perceived quality of life. The effect of the interventions on nausea - a common side effect of chemotherapy - is also being assessed. Also of interest is whether interventions requiring specific psychological training (i.e. cognitive behavioural therapy) add anything to the outcomes achieved by simple relaxation training which could be carried out by a wide range of health professionals.

  • 'Taking control of Bipolar Disorder: staying well, learning more': a 12 month Randomised controlled trial evaluating an online relapse prevention program for bipolar disorder

    Bipolar disorder is a chronic relapsing remitting illness which affects 1-2% of the general population. It is rated as being the 6th highest cause of disability world wide (WHO figures) despite recent advances in psychopharmacotherapy. The recognition for a more holistic approach to treatment has emerged with studies showing the positive benefits of a number of psychological interventions including individual and group psychoeducation, cognitive behavioural therapy and family therapy. However, despite recognition of their importance, as seen by their inclusion in the recent RANZCP treatment guidelines for bipolar disorder, they are not part of standardised clinical practice within local mental health services for many reasons. The Internet is now increasingly being used to deliver a variety of interventions for people living with a chronic illness. A recent study (BMJ 2003) showed that an web-based cognitive behavioural therapy program (Mood Gym) produced statistically significant reductions in the symptoms of depression in its users. The purpose of this study is to determine if programs designed for and delivered over the internet can help people with bipolar disorder stay well. Specifically if such programs can help reduce symptoms, reduce rates of relapse and admissions into hospital and assist people to remain on medication. This study is a randomised controlled trial, which means that if found to be suitable for inclusion into the study, all participants will be randomly assigned to one of two treatment groups, either ‘Bipolar Disorder Recovery Road’ or 'The Virtual Highway for Bipolar Disorder’. The ‘Bipolar Disorder Recovery Road’ program consists of twenty sessions and will be presented over a 12-month period. It will allow participants access to the following Internet-based features: • personal medical record including a medications record. • questionnaires that monitor progress and provide feedback via graphs • an online diary • specific educational material on bipolar disorder and its treatment, presented on a session by session basis; With information delivered under sections entitled ‘Dealing with Symptoms’, ‘Managing Side Effects’, ‘Medication Issues’ , ‘Psychological Issues’ and ‘Staying Safe’. • further educational material referred to as ‘suggested readings’ provides further more detailed information to assist in making treatment decisions. • 12 sessions of Cognitive Behavioural Therapy (CBT) designed to help identify early warning signs and to manage symptoms. • Regular email reminders to take medication and to logon into the program. • Access to 'Website of the week' The 'Bipolar Disorder Virtual Highway’ program will run over same time frame and will allow participants access to the following Internet-based features : • Personal medical record including a medications record. • Questionnaires that monitor progress • Online diary • ‘Website Virtual Tour’ feature which provides links to quality assessed websites offering variety of information about healthy lifestyles and ways to stay well. On completion of the Virtual Highway Program for Bipolar Disorder, all participants will be eligible to be enrolled into the 'Bipolar Disorder Recovery Road' program for a further 12 months ( free of charge).

  • Expressive Writing: An investigation of whether and how writing about stressful experiences can be used to enhance psychological and physical well-being in recently treated adult cancer patients and healthy community volunteers

    The Expressive Writing technique involves writing about a stressful experience using both emotional and factual descriptive words utlising a journal format. The technique has been found to be helpful in improving psychological and physical health functioning in various populations, under experimental conditions. Researchers have yet to adequately explain how this technique leads to health benefits. The aim of this study is to investigate how the Expressive Writing task leads to positive health functioning in two distinct populations; cancer survivors and healthy individuals. The study outcomes will be helpful in identifying how this task can be adapted to be used as a therapeutic technique in clinical health settings, to enhance the well-being of Australians.

  • Use of the anaesthetic conserving device in the Intensive Care

    Patients who are post cardiac surgery, and frequently patients after other prolonged surgery require mechanical ventilation in the ICU until they are stable for extubation. The majority of these patients require some sedation, mainly for endotracheal tube tolerance, cough suppression and to allow routine procedures be performed. Currently , intravenous sedatives are used in our ICU. The use of inhalational agents such as Sevoflurane and Isoflurane in the intensive care setting, has been widely described in the literature. The advantage of these agents are that they are easily titrated to effect, the level of sedation can be easily monitored, and as they are exceted by the lungs, and not by the liver and kidneys, may be more advantageous in patients with hepatic or renal impairment. Furthermore more, they have been shown to have a cardioprotective effect on those post cardiac surgery in particular and reduce the morbidity and mortality in this group. In our study, we will enrol 10 patients post CABG surgery to receive Isoflurane via the Anaesthetic Conserving Device (AnaConDa) until the time of extubation. We believe that the time to extubation following cessation of sedation will be shorter compared to those receiving intravenous sedation. We will measure troponin levels, which is a marker of cardiac injury, and compare the levels in those receiving inhalational sedation compared to intravenous sedation. Patients’ cardiac and respiratory status will be carefully monitored in the ICU setting, and their sedation scores measured. We believe we can reduce the amount of intravenous sedation used in this group.

  • The Study of Mental Activity and Regular Training for the Prevention of Cognitive Decline in at Risk Individuals: The SMART Trial

    Over 200,000 individuals are affected by dementia in Australia, with many more individuals at-risk by virtue of borderline cognitive impairment. The personal, social and economic impact is therefore significant and projected to increase due to the ageing of the population. Even relatively modest goals, however, such as delaying the onset of dementia by a few years could have a large impact on the burden to individuals and society. New strategies aimed at preventing cognitive decline are therefore an urgent priority. In this regard, there is mounting evidence that involvement in a variety of mentally and physically stimulating activities throughout life may be important for optimal brain function and a reduced occurrence of memory problems in older adults. There is also some evidence that even when started in later life, mental and physical exercises can maintain or improve brain function compared to those who do not engage in such activities. However, the best type or combination of activities to achieve such benefits is far from clear. In addition, whether such techniques would work in those who have already developed mild changes in mental function is largely unknown. Therefore, we have designed a robust clinical trial in which individuals who have early changes in memory or thinking ability without an identified cause will be randomly assigned to mental exercises, weight lifting exercise, both interventions together, or a control condition. Participants will have their cognitive abilities tested after 1 year to ascertain whether lasting benefits do occur. In addition, brain size and biochemistry will be assessed using sophisticated magnetic resonance imaging studies. Associated improvements in fitness, body fat, mood, risk for other chronic diseases, and independence and quality of life will also be measured. This study will therefore provide the first comparison of the isolated and combined effects of these two interventions in an older sample at risk for dementia, as well as provide new insights into possible biological changes underlying these benefits. Statistical Analysis Strategy: Primary outcomes will be analysed by intention-to-treat analysis with imputation of missing data using the expectation maximization algorithm and/or mixed model regression techniques. Secondary analyses of primary outcomes will include all available data and per protocol analytic strategies, in order to investigate any potential dose-response effect of our interventions. Secondary outcomes will be analysed using all available data.

  • Breathe easier during exercise ~ Can Heliox improve the sensation of breathlessness and increase exercise duration in people with COPD

    Distress with breathing or shortness of breath can be a debilitating experience for people suffering from lung diseases. The severity of this sensation often precludes individuals from maintaining a normal active lifestyle. As the severity of the shortness of breath increases, so the activity performed decreases, often to the point where moving from one’s bed or chair can be exhausting. The general physical and mental health consequences of this are such that these individuals and those who care for them have a significantly lower social and mental health well being. The severity of breathlessness and impairment of activity have been shown to correlate strongly with increased hospitalizations and a longer time to recovery once their condition has worsened, as in the case of exacerbations. It is hoped that a low density gas mix, such as Heliox (21 % oxygen in balance Helium), can reduce the magnitude of muscular effort associated with breathing in patients with chronic obstructive pulmonary diseases (COPD) and allow for an alteration in both the sensation and magnitude of dyspnoea allowing patients to exercise longer and at greater intensities., thus facilitating a training effect. This would allow these individuals to improve their social activity, mental health and their quality of life whilst reducing the recovery time resultant from a transient worsening of their conditions (infective exacerbations of COPD) which may have otherwise predisposed hospitalization.

  • A randomised controlled trial of non-invasive cardiac output monitoring in the emergency room:

    Critically ill patients often have signs of inadequate oxygen delivery. We know this adversely impacts on survival. The hypothesis is that the introduction of non invasive cardiac output monitoring will allow us to improve or correct oxygen delivery, thus possibly improving survival

  • Stretching in Cystic Fibrosis: Does it improve quality of life?

    Cystic Fibrosis (CF) is a commonly inherited genetic disorder affecting numerous bodily systems, with great impact on the respiratory system including thoracic muscles. Although musculoskeletal problems such as back pain appear to be common in CF patients, there has been little research conducted to investigate the efficacy of musculoskeletal techniques such as stretching in this population. Cystic fibrosis patients are invited to take part in a study to investigate the effects of stretching exercises on quality of life. Background You will be invited to attend one session, lasting 60 minutes at the Department of Physiotherapy, Prince Charles Hospital, where a physiotherapist will assess the following: 1.How much air you can breathe out in 1 second, repeated up to 6 times 2.Amount of movement you have in your arms, using a device to measure angles 3.How much you move your upper, middle and lower chest during breathing, by placing a tape measure around your chest and asking you to breathe in and out 3 times. 4.Measuring the curve of your thoracic spine by placing a soft mouldable ruler over your spine while standing 5.Fill out a questionnaire containing questions regarding your quality of life. 6.Fill out a questionnaire containing questions how your pain affects your daily tasks After the 1st session, you will be randomly allocated to one of the following groups. Arm stretches group: This involves completing a series of stretches for your arms and trunk over the 6 week period. Your physiotherapist will show you these exercises. You will be asked to do these once a day over the study period and complete a diary of how many exercises you performed each day. Leg stretches group: This involves completing a series of stretches for your legs over the 6 week period. Your physiotherapist will show you these exercises. You will be asked to do these once a day over the study period and complete a diary of how many exercises you performed each day. At the end of the 6 week period, you will be asked to attend another visit to repeat the above measures. Benefits Your participation in the study is not likely to benefit you directly but may assist in the development of future rehabilitation programs for patients with cystic fibrosis.

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