ANZCTR search results

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

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31383 results sorted by trial registration date.
  • Sexuality After Breast Cancer

    Vaginal dryness and dyspareunia (pain occurring during sexual intercourse) is a common consequence of treatment for breast cancer and has been identified as one of the most common and troublesome consequences for survivors. Vaginal dryness and pain during sexual intercourse significantly negatively impacts on quality of life. With improved survival from breast cancer the absolute number of breast cancer patients affected by symptomatic vaginal dryness and dyspareunia is likely to increase. Systemic or topical (vaginal) estrogens are an effective treatment for symptoms of vaginal dryness. However, the safety of vaginal oestrogens after breast cancer is not established. Water-based lubricants are widely used and silicone based lubricants are also available for vaginal lubrication. However, the relative effectiveness and acceptability of these products is not known. No previous studies have evaluated silicone-based vaginal lubricants for the treatment of vaginal dryness and dyspareunia after breast cancer or compared these with water-based lubricants. Aims: The primary aim of this study is to compare the efficacy and acceptability of a silicone-based vaginal lubricant vs. a water-based lubricant in breast cancer patients with symptomatic vaginal dryness using a randomised cross over design. The Secondary Objective is to clinically assess the symptoms and signs of vaginal dryness, evaluate quality of life and sexual function using established questionnaires. Study Population: 40 subjects with a history of breast cancer complaining of vaginal dryness will be recruited from the Menopause After Cancer Clinic (MSAC) at The Royal Women’s Hospital Melbourne (RWH), the RWH Breast Clinic, oncologist practices in Victoria and community based breast cancer organisations such as the Breast Cancer Network Australia and by media advertising. Methods: To participate in this study subjects must have a history of breast cancer, be sexually active and be complaining of vaginal dryness for at least 4 weeks. Subjects will be asked to attend 3 clinic visits. Ethical Issues: Subjects will be asked to complete questionnaires including details of sexual problems and function and to complete a sexual activity diary. Subjects will be fully informed of the requirements before enrolling in the study and able to withdraw at any time without compromising their care. These vaginal lubricants are not systemically absorbed and are extremely unlikely to impact on breast cancer management or prognosis.

  • Study to Demonstrate the Safety and Efficacy of the CARDIVA VASCADE Vascular Closure System (VCS) versus Manual Compression

    The Cardiva VASCADE VCS consists of a sterile disposable catheter containing a deployable extravascular collagen path and a clip. The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE Vascular Closure System (VCS) in sealing femoral access sites and providing reduced times to hemostasis, time to ambulation, and time to discharge eligibility compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths.

  • Study to Demonstrate the Safety and Performance of the VASCADE 5F Vascular Closure System (VCS)

    The Cardiva VASCADE VCS consists of a sterile disposable catheter containing a deployable extravascular collagen path and a clip. The VASCADE VCS is intended to seal or close the femoral arterial access site while reducing time to hemostasis (stop the bleeding process), time to ambulation (when a person can walk), and time to hospital discharge in subjects who have undergone diagnostic or interventional endovascular procedures.

  • Establishing an effective and efficient Early Supported Discharge (ESD) rehabilitation program for Stroke clients in Perth WA

    Early Supported Discharge (ESD) rehabilitation is considered internationally as best practice in rehabilitation of mild and moderate strokes when transferring from hospital to home. At RPH there are approximately 500 admissions for stroke. This research study will undertake a randomised controlled trial comparing an early discharge strategy to that of normal care in 90 individuals with mild and moderate stroke admitted to Royal Perth Hospital. This research study is designed to optimise the rehabilitation processes and pathway of people who have recently had a stroke. This study is a cost utility analysis of processes associated with the pathway of individuals admitted to RPH with mild or moderate stroke. The proposed change in model of care (ESD process) may have an impact on acute LOS and we would like to test the hypothesis that if there is a change that it will not detract from the long term functional outcomes nor satisfaction of the clients Hypothesis: H1: That the ESD strategy decreases LOS when compared to a matched cohort with no difference in functional outcomes at 6 and 12 months.

  • Sealants for smooth surface caries prevention in children

    Traditional approaches for preventing proximal lesions such as flossing and rinsing with fluoride usually have limited success as they rely heavily on patients’ compliance (Alm et al. 2007). More recently, treatment of proximal caries has been focussed on arresting initial caries by sealing these lesions with low viscosity resins (Ekstrand et al. 2010). Although early success has been reported using this technique, there is a need to gain access to the proximal lesions which requires physical separation of the teeth. As this technique usually involves two appointments, it is not practical for young children. A more conservative alternative would be to seal the teeth while it is possible to gain access to the proximal smooth surfaces before the contacts with adjacent teeth are established. There are a few stages in the development of the primary and permanent dentitions which provide windows of opportunity to gain such access to specific proximal surfaces of the posterior teeth. HYPOTHESIS We hypothesize that smooth surface sealants (SSS) placed prior to establishment of the proximal contacts can prevent proximal caries in teeth. AIMS Therefore the aims of the study are to: (1) Determine the caries incidence in sealed surfaces of primary and secondary teeth compared to unsealed surfaces in the same teeth in other quadrants of the mouth. (2) Evaluate the cost effectiveness of smooth surface sealants in preventing caries

  • Randomised Controlled Trial of a Traditional and Modified Healing Program for Enhancing Social Emotional Well-Being in Indigenous Australian Children

    This study will randomly allocate participants to either (a) Healing Program, or (b) Healing Program + Cognitive Behaviour Therapy.

  • Asses the safety and efficacy of switching to tenofovir and lamivudine therapy in patients who have been receiving Hepatitis B Immunoglobulin and lamivudine prophylasix post liver transplant.

    The use of the combination of lamivudine (LAM) and low dose hepatitis B immune globulin (HBIg) prophylaxis has had a major impact on the rate of recurrence of hepatitis B following liver transplantation. However, the long-term use of HBIg is extremely costly and very inconvenient for patients. There is a clear need to develop an alternative more convenient and less costly long-term prophylactic regimen for use in this patient group. The aim of the proposed study is to assess the safety and efficacy of switching to tenofovir and lamivudine therapy in patients who have been receiving long-term HBIg and lamivudine prophylaxis post-liver transplant.

  • Randomised controlled trial comparing the Ambu Ascope with conventional fibreoptic bronchoscope in asleep orotracheal intubation of adult patients undergoing general anaesthesia

    This research is designed to specifically compare the performance of the bronchoscopes in the clinical setting using a validated rating scale for bronchoscopic performance – the Global Rating Scale

  • Can an acute dosage of Bacopa Monniera (brahmi) improve cognition and cardiovascular function in a healthy population

    This research project is aiming to determine the effects of Bacopa on cognitive function, cardiovascular function and stress. Bacopa is a herb found in wetlands and muddy shore lines that has been used in traditional Indian medicine as a treatment for epilepsy and asthma. Russo & Borrelli (2005) claim that it has been used for over 3000 years as a memory and intellect enhancer. There is also evidence to suggest that Bacopa is an antioxidant, playing an important role in reducing the oxidation of fats in the bloodstream. This study will investigate the cognitive, cardiovascular and stress effects of two doses of bacopa compared to placebo. Participants will be required to attend three testing sessions (and one practice session). Each session will see participants taking one of three interventions (administered in capsules); (1) Bacopa Monniera – 300mg (2 x 150mg capsules, 2 x placebo capsules) (2) Bacopa Monneria – 600mg (4 x 150mg capsules) (3) Placebo (4 x capsules) On the testing days participants will complete baseline testing (consisting of the Cognitive demand battery and cardiovascular measures) after which they will be administered their randomly assigned treatment. Two hours post dose participant will complete the testing again (Cognitive demand battery and cardiovascular measures). There will be a seven day washout period and the process will be repeated again. Over the course of the investigation, participants will complete all three treatments with treatment order being randomised and counter! balanced across participants. Russo, A. and F. Borrelli (2005). "Bacopa monniera, a reputed nootropic plant: an overview." Phytomedicine 12(4): 305-317.

  • An international collaborative (AIEOP-BFM [Associazione Italiana Ematologia Oncologia Pediatrica - Berlin-Franklin-Munster]) treatment protocol for children and adolescents with Acute Lymphoblastic Leukaemia

    This is a clinical trial investigating improved outcomes for children and adolescents with acute lymphoblastic leukaemia. Who is it for? You (or your child) may be eligible to join this study if you are aged between 1 and 18 years of age, and have been newly diagnosed with acute lymphoblastic leukaemia.The Study 9 research study is being done in order to maximise the chance of curing your child’s ALL while at the same time lowering the chance of significant short- and long-term side effects.

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