ANZCTR search results

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

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33074 results sorted by trial registration date.
  • Effectiveness of Clinical Exercise Physiology Interventions on Physical Activity, Quality of Life and Clinical Prognosis in Type II Diabetes

    Exercise Physiologists are a relatively new allied health profession. The exercise physiologist provides exercise counselling with the objective being to improve various health related parameters for the client. However to date there is virtually no research available to confirm or refute the efficacy of the exercise physiologist in producing meaningful improvements in the health of an individual. A number of studies have reported exercise training leads to positive health outcomes in type II diabetes. An issue with these studies is that they are highly controlled. While this is desirable from the point of view of determining effects, it is often not reproducible in an applied setting and may not readily transform to patients continuing the exercise in a less controlled setting such as occurs in clinical practice. The study will follow the changes in health markers in approximately 500 type II diabetics who undergo exercise physiology counselling in a clinical practice setting. A range of measures of physical function, participation in physical activity, quality of life and clinical prognosis will be measured on commencement in the study and after six months of treatment. The number of sessions with an exercise physiologist and whether or not patients received treatment with another allied health professional will be used as co-variates in the statistical analyses.

  • CAMERA - Combination Antibiotic treatment for Methicillin Resistant Staphylococcus Aureus

    MRSA bacteraemia has a mortality of 30-40%, exceeding that of sensitive Staphylococcus aureus primarily due to the shortcomings of vancomycin, the standard therapy for MRSA bacteraemia. Whilst several new antibiotics have become available for MRSA, none have been shown to be superior to vancomycin. Although MRSA is by definition resistant to oxacillin, multiple in-vitro and animal studies have demonstrated synergy of vancomycin with beta-lactams (including oxacillin) against MRSA and hetro-resistant vancomycin intermediate Staphylococcus aureus (hVISA). This study aims to answer the following question: In hospitalised adults with MRSA bacteraemia, does combination therapy with vancomycin and flucloxacillin lead to a shorter time to clearance of bacteraemia than vancomycin alone?

  • The ProCare Trial: A randomised controlled trial of follow up of men with prostate cancer in primary care.

    The primary purpose of this trial is to develop and test a model of shared care follow-up for men with prostate cancer with the aim of reducing unmet needs and psychological distress. Who is it for? You may be eligible to join this trial if you are aged 18 years or over and have been diagnosed with prostate cancer for which you have completed surgery and / or radiotherapy with curative intent at Royal Perth Hospital and at Fremantle Hospital in Western Australia, within three weeks of study entry. You will also need to have a GP who agrees to participate in the trial. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive usual care (in accordance with local hospital practice). Participants in the other group will receive shared care, whereby some of the routine hospital visits are replaced by GP visits over the 12 month follow-up period. The trial aims to test whether a shared care model of follow-up for prostate cancer may reduce rates of psychological distress and unmet psychosocial and psychosexual needs and improve satisfaction with care at lower cost compared to usual care.

  • Prevention of Lowered Mood in Major Depressive Disorder with Quetiapine extended release after remission has been induced by electroconvulsive therapy (ECT)

    There is emerging that the medication, Quetiapine (trade name: Seroquel) is clinically useful in treating clinically significant depression (major depressive disorder) and in the augmentation of antidepressant medication in this condition and depression that occurs in bipolar disorder (manic-depression). Quetiapine is currently approved for the treatment of schizophrenia and bipolar disorder. This study will look at whether the addition of the medication Quetiapine XR (trade name: Seroquel XR) to standard antidepressant medication is better than antidepressant medication alone in keeping symptoms of depression to a minimum after a clinically beneficial course of electroconvulsive therapy (ECT) within the previous 3 weeks for clinical depression (major depressive disorder). Participation in the study will occur after remission (disappearance) of clinically significant depression has occurred after treatment with ECT, when there has been failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment. People will be invited to participate in the study if they: are aged 18-65 years ;have been diagnosed as experiencing major depressive disorder; have had a course of ECT completed within the previous 3 weeks, which has led to remission of depression sustained over the last 2 ECT treatments of the ECT course, after failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment. People will not be able to participate in the study if they are: at immediate risk to themselves or others; dependent on alcohol or other substances, apart from caffeine or nicotine; or have diabetes mellitus that is not stable or well controlled. Women who are pregnant, or may become pregnant, or are lactating during the course of the study, will also not be able to participate in the study. There will be 2 groups of 20 participants, each, in the study. One group will be treated with the medication Quetiapine XR in combination with an antidepressant medication. Another group will be treated with an antidepressant medication alone. The antidepressant medications, either a selective serotonin reuptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) that has not been previously prescribed, or previously not helpful in preventing relapse of clinically significant depression, will be prescribed by treating doctors. The addition of Quetiapine XR to the antidepressant medication will be randomly determined, so that the study doctors or treating doctors will have no prior knowledge nor influence on whether this medication is added to prescribed antidepressant medication. The dose of Quetiapine XR will range from 50 milligrams to a maximum of 300 milligrams per day, with doses adjusted according to clinical response to, and tolerability of this medication. Psychiatric medications other than the prescribed antidepressant medication or Quetiapine XR, will not be prescribed or permitted during the course of the study. The duration of the study is 6 months, with weekly study visits for the first month and monthly, thereafter for the remaining 5 months. Participants will be asked questions about the presence of depressive symptoms and how they are tolerating their medication, as well as a physical examination as part of each study visit. Participants will have blood tests (clinical chemistry, haematology) prior to commencing the study, and at 1,2,3 and 6 months. Participants will also have a fasting (not having eaten, or drunk anything other than water since midnight) prior to commencing the study, and at 3 and 6 months. Participants will also have a urine drug test and electrocardiogram (ECG) prior to commencement. Participants will be free to withdraw their consent at any stage without affecting or prejudicing their clinical care in any way. In the event of depressive relapse (recurrence of clinically significant depression), participants will be discontinued from study, with alternative treatment arrangements made in consultation with their primary treating medical practitioner.

  • Optical coherence tomography in the assessment of breast cancer

    This study looks at whether a new imaging technique, referred to as optical coherence tomography (OCT), is as accurate as histology (examining cells under a microscope) in identifying cancerous tissue in people with breast cancer. Who is it for? You can join this study if you are a woman or man with breast cancer and are about to undergo surgery. Trial details In this preliminary study, OCT images of tissue samples removed during surgery will be compared to standard histology, to see whether OCT can reliably distinguish cancerous and healthy tissue. OCT is an imaging technique which acquires high resolution images of tissue. It is similar to ultrasound, but uses reflections of near infrared light waves instead of sound waves. OCT could potentially be used on tissue before it is cut out of the patient, which would avoid the unnecessary removal of healthy tissue during breast cancer surgery. Results from this trial will form the basis for future trials which will be performed on human tissue prior to removal of the tissue from the patient.

  • A study to assess the efficacy of a probiotic in the restoration of bowel function of patients undergoing reversal of ileostomy.

    Patients experience a period of altered bowel function after the reversal of a temporary loop ileostomy. This study aimed to assess whether a probiotic preparation, VSL#3, improved bowel function during the first month after loop ileostomy reversal.

  • Environments for Healthy Living, Griffith Study of Population Health: Longitudinal Birth Cohort Study, Child Development and Health.

    The longitudinal birth cohort study Environments for Healthy Living (EFHL) is designed to collect information from before birth through to 25 years of age across a spectrum of eco-epidemiological factors, including but not limited to, genetic material from cord-blood samples at birth, individual and familial factors to spatial data on the living environment. The EFHL study has had an annual four month recruitment of mothers since 2006. Detailed information on each participant is obtained at birth, 12-months, 3 years, five years and at subsequent three to five yearly intervals. Data collected is centred on both mother and child and includes questions about nutrition, parenting style, psychological factors, child behaviour, physical activity, attachment behaviours, quality of life, illnesses and injuries, health outcomes, utilisation of health care services, and socioeconomic factors (e.g. income, education, family structure and cultural identity). Findings will be used to identify where improvements can be made within the community to make health and lifestyle choices easier for families. The study will assist in discovering the best ways to reduce the major health problems facing Australians today, such as obesity, asthma, cardiovascular disease, cancer, diabetes, injury, mental health and musculoskeletal disorders.

  • A randomised Phase III Trial to assess response adapted therapy using 2-[F-18]fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma

    This study looks at the effectiveness of using fluoro-deoxy-glucose positron emission tomography (FDG-PET) imaging to guide therapy in people with newly diagnosed, advanced Hodgkin lymphoma. Who is it for? You may be able to join this study if you have previously untreated advanced Hodgkin lymphoma and are over 18 years of age. Trial details Participants receive 2 cycles of the standard chemotherapy regimen (ABVD) and then have a FDG-PET scan, which provides a 3 dimensional image of the lymphoma. Depending on the results of this and future scans, participants are assigned different courses of chemotherapy at various stages during the trial. The trial aims to see how the different treatments, which are guided by the results of FDG-PET imaging, affect survival rates, and also monitors any toxic effects of treatment.

  • A comparison of ultrasound guided and nerve stimulator assisted popliteal nerve blocks for foot surgery

    This project has been designed to investigate whether one particular method of administering local anaesthetic around the knee in order to provide pain relief for patients undergoing foot surgery is better than the other. A routine part of anaesthesia for foot surgery performed in our unit is to perform a popliteal block. This involves injecting local anaesthetic around the nerves behind the knee to numb the foot and provide pain relief both during and after the operation. This block is performed either using an ultrasound machine to visualise the nerves or a nerve stimulator which stimulates the nerve. Both allow the anaesthetist to know the correct position to inject the local anaesthetic. We are planning to randomly allocate patients undergoing foot surgery to receive the block either with the ultrasound machine or with the nerve stimulator. We will then use a form to collect information about pain and pain relief requirements whilst the patient is in hospital to assess the efficacy of the block. We will also collect information about the length time to perform each block and patient satisfaction. Patients will be seen at routine follow up at 8 weeks and assessed to see if there are any ongoing problems related to the nerve block. We will analyse the data to see if one technique is superior to the other and modify our practise as appropriate.

  • Panobinostat with 5-azacytidine in patients with untreated high risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML).

    This study looks at the effectiveness of the drug panobinostat in combination with 5-azacytidine in treating people who have recently been diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Who is it for? You can join this study if you are aged 55 or greater and have recently been diagnosed with high risk myelodysplastic syndrome or acute myeloid leukaemia, and you are unsuitable for or unwilling to undergo standard therapy. Trial details Participants will receive treatment with the anti-cancer drugs panobinostat (taken orally) and 5-azazytidine (administered via injection) over six 28 day cycles, On completion of this initial treatment, all patients not experiencing disease progression will receive further combination therapy with panobinostat and 5-azazytidine based on their degree of disease response. This will be followed by maintenance therapy with panobinostat alone. The study aims to determine the safety, tolerability and efficacy of treatment.

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