ANZCTR search results

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

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32914 results sorted by trial registration date.
  • Randomised double-blind controlled trial of the use of daily sildenafil (Viagra) in men with early prostate cancer treated with radiation, for the prevention of subsequent erectile dysfunction.

    All staff and patients will be blinded from allocation of active agent/placebo. Only authorised clinical trial pharmacy staff will have access to this information. If a medical emergency requires unblinding, the principal investigator is required to provide authorisation for clinical trial pharmacy staff to unblind.

  • The effect of Synbiotics in humans on biomarkers of risk for colorectal cancer (CRC)

    This study will explore the potential of synbiotic combination of probiotic bacteria and resistant starch (RS) to improve health and reduce the risk of colon cancer. Participants will be asked to include in their diet either resistant starch or a probiotic or a combination of the two. Markers of the health value of these dietary agents will then be examined in samples of faeces, blood and samples taken from the lining of the bowel wall. Since the greatest risk of CRC is due to lifestyle (in particular diet) rather than genetic predisposition (family/hereditary bias), defining the disease mechanism and finding ways to prevent its occurrence are of significant importance. The proposed study will help provide valuable information on how resistant starch can be used to improve colon health, provide data on the prebiotic use of resistant starch and detailed information on a “synbiotic formulation” that is already on the market. The study participants (subjects) and the data analyst will be blinded. The probiotic bacteria will be in the form of boxes of capsules labelled - B The resistant starch will be in powder form in sachets labelled - A The combination will be A + B The resistant starch placebo will be labelled - C The placebo probiotic will be labelled - D Example: Pt 1 will be allocated with First 4 weeks A+B, then A and then final 4 weeks B Their boxes and sachets will be labelled A+B, A+D & B+C respectively.

  • Diet and physical exercise prior and during In Vitro Fertilization (IVF) in infertile overweight women.

    This interventional study will assess the effects of a moderate caloric restriction and progressive exercise prior and during In vitro Fertilization in overweight / obese infertile women on treatment outcomes.

  • Anti-atherosclerosis Drug Evaluation Platform

    An independent contractor will fill and label the vials. The capsules and vials between medicine and placebo will be identical. Each vial will have a unique identifier which will allow the data to be properly decoded at the conclusion of the study. The patient and the physician/hospital staff, etc will be blinded.

  • Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.

    Therapeutic options for patients with metastatic colorectal cancer whose cancers have progressed after treatment with standard therapies are limited. Cetuximab therapy is a new treatment targeting the epidermal growth factor receptor (EGFR, a protein on the surface of many cancer cells). Cetuximab can attach to this protein and may stop cancer growth. This study will examine the effect of cetuximab on length and quality of life in people with advanced EGFR positive colorectal cancer whose cancer has progressed after chemotherapy.

  • A randomised controlled trial of a letter intervention in primary care patients to improve depression and anxiety disorders

    The purpose of the study is to investigate whether patients who receive a copy of the psychiatric assessement letter that is sent to their GP have improved adherence to treatment recommendations. There are two hypotheses: 1. receiving the assessment report will improve patient adherence to treatment recommendations; 2. that receiving the assessment report will improve patient outcomes.

  • The Concord Repatriation General Hospital Intensive Care Quality of Care Study

    BACKGROUND It is speculated that involvement of Palliative Care teams with patients in the Intensive Care Unit (ICU) receiving end-of-life care may lead to better patient, family, and staff satisfaction with the care provided in the ICU, but this has not been studied before. Palliative Care teams have been shown to improve many measures of outcome, such as symptom control, patient and family or carer satisfaction, and health care costs in several other medical settings. AIM The aim of this study is to examine the effect that the Palliative Care team has on outcomes in patients receiving end-of-life care in the ICU. HYPOTHESIS Our hypothesis is that the involvement of the palliative care team in patients receiving end-of-life care in the ICU improves patient and staff quality indicators for end-of-life care. RESEARCH PLAN This pilot study is a single centre, unblinded, prospective, randomised, controlled trial in patients in the ICU, in whom the treating doctors believe that the current medical condition is terminal or pre-terminal, and that treatment should either be withdrawn or not escalated. Patients will be eligible for the study, if they suffer from a terminal or pre-terminal condition, and if the treating ICU physician, in consultation and agreement with the treating parent team, deems it appropriate for end-of-life care to be started, and deems it appropriate that current treatment either should have limitations imposed and should not be escalated, or should be withdrawn or withheld. Enrolment will begin after the treating ICU consultant has discussed the medical issues with the patient and/or their family and has indicated that it is their professional belief that treatment should not be escalated and palliative care should be instituted. Enrolment will be via direct approach from research staff. Consenting patients will be divided randomly into 2 groups. The control group will have usual, standard ICU care. The study group will have usual, standard ICU care, and in addition, a Palliative Care Team will consult. Consenting families will be asked to complete 2 questionnaires; one soon after the initial enrolment discussion, and a second questionnaire after the patient's death or transfer out of the ICU. Medical and nursing staff will also be asked to complete similar questionnaires. The questionnaires will ask questions on several quality indicators for end-of-life care, such as communication, continuity of care, emotional and practical support, symptom management, decision making, and other aspects of support. As outcome data is currently unknown, a blinded analysis will occur after 40 patients have been enrolled to determine the sample size required for significance. We intend to enrol 180 patients, in line with our current predictions for statistical significance. Analysis will be on intention to treat. Non-parametric testing will be used to analyse differences between the two groups. This study is a 3 year pilot study, with the aim of constructing a larger, multi-centre trial after completion. OUTCOMES AND SIGNIFICANCE The primary outcomes will be composite scores for patient/family satisfaction with care in the ICU, composite scores for staff satisfaction with care in the ICU, and length of ICU and hospital stay. End-of-life care in the ICU is currently a significant problem in Australia. With the change in philosophy in medical care from paternalism to consumerism, many patients are now demanding expensive, but futile medical care. Many patients receive treatment and organ support, not because the treatment is indicated, but for other reasons. Palliative Care has been shown to improve end-of-life care in many areas outside of ICU, and has also been shown to reduce health care costs in these areas. We expect this study will be significant in demonstrating that Palliative Care teams can help improve end-of-life care outcomes, and reduce health care costs in the ICU.

  • A Randomised Controlled Trial Comparing Two Different Knee Exercise Programmes in the management of Adolescents with Symptomatic Joint Hypermobility

    Joint Hypermobility Syndrome is a common but poorly recognised condition which mainly affects children. Joint hypermobility or double-jointedness can result in significant symptoms of pain, often described as growing pains, and symptoms of fatigue. This research study aims to find out what the best set of physiotherapy exercises is to reduce knee pain in individuals with joint hypermobility and pain. We are looking to recriut 40 teenagers aged 12-16 with knees that bend backward and are sore and give them 8 weeks of physiotherapy to see if it helps with the pain. Physiotherapy is the recommended treatment in this situation but reaserch to prove that it works has never been done, also different hospitals recommend different types of physiotherapy exercises and we will try and find out which ones work best or if there is no difference.

  • The impact of Biannual followup at a specialist Endocrinology Clinic to manage osteoporosis through medication and lifestyle modification on compliance with medication, incidence of fractures and changes in bone mineral metabolism, in Patients Presenting to Hospital with a Minimal Trauma Fracture

    A prospective study to screen for osteoporosis in all patients presenting to Concord Hospital with a minimal trauma fracture, and to initiate appropriate treatment in osteoporotic patients. The aim is to assess, in a randomised study, the efficacy of semi-annual specialist reviews vs. GP follow-up in terms of compliance and osteoporosis complications.

  • Weight Loss & Cardiovascular Risk in Type 2 Diabetes Study

    The principal aim of this research project is to determine the separate effects of energy restriction/weight loss and aerobic exercise training on blood vessel function in sedentary overweight and obese subjects with type 2 diabetes. It is a secondary aim to evaluate whether physical exercise training and weight loss will enhance antioxidant capacity, reduce oxidative stress and increase nitric oxide bioavailability

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