ANZCTR search results

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

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32857 results sorted by trial registration date.
  • Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy.

    Female anterior pelvic organ prolapse (POP) is common. In POP, the vaginal tissues become weak, causing descent of vaginal walls. In moderate to severe anterior POP, conservative treatments may be unsuccessful. In these cases surgical treatments can include: *Surgical repair with a patient’s own tissue (anterior colporrhaphy) *Surgical repair with reinforcement using a tissue graft to provide additional support. The aim of this study is to compare two established surgical techniques for anterior POP to determine which has the best result. The primary outcome will be measured using the following criteria. All three must be met qualify as success: 1) objective measures (anatomical), 2) subjective measures (validated quality of life questionnaire), 3) participant not having repeat procedure for anterior POP recurrence. The primary outcome will be assessed at one year after surgery. This is a multicentre blinded prospective randomised trial. Participants will be randomised to: 1. Anterior colporrhaphy 2. Xenform anterior vaginal repair Both procedures are routinely performed by urogynaecologists in the private and public sectors. Xenform Matrix (Boston Scientific, Marlborough, MA, USA) is used in Australia and by the urogynaecologists in Perth in the private and public sectors for surgical repair of POP. Xenform has been approved since 2010 for POP repair by the Australian Therapeutic Goods Administration. For the participants at Hollywood Private Hospital, they will be recruited from the surgeon’s private rooms. Participants will be eligible if they have symptomatic anterior POP to the level of the hymen and desire surgical treatment. At recruitment, participants will have a pelvic examination to assess pelvic organ prolapse quantification (POP-Q as per International Continence Society). A validated quality of life questionnaire (QoL) (Pelvic Floor Distress Inventory Short Form 20) will also be administered. POP-Q and PFDI-20 will be repeated one year after the operation.

  • Making active choices more attractive: Do physical activity incentives improve heart health?

    This project aims to test the feasibility and effectiveness of incentives for promoting increased physical activity, decreased sedentary behaviour, and improvements in heart health risk factors among adults. We hypothesised that an intervention involving relatively small, intermittent incentives in the form of points exchangeable for gift vouchers, offered over a 4-month period, and supplemented by an initial motivational interview and regular motivational text (mobile-phone SMS) messages, will lead to significant increases in time spent in physical activity; decreases in time spent in sedentary behaviours; and decreases in BMI and blood pressure, among middle-aged (40-65 year old) adults. Participants receive one point per minute, capped at 30 minutes per day, for engaging in physical activity; and one point per minute, also capped at 30 minutes per day, for reducing their sedentary time. Physical activity and sedentary time are monitored using a Fitbit One device provided to participants and linked to a purpose-designed study website that records points.

  • The feasibility and utility of using an accessible controller to improve motor and sensory function in people recovering from stroke through computer gaming: A randomised controlled pilot study.

    Rehabilitation can be a long process for people after stroke, and needs to be intensive to drive functional recovery. Computer gaming is proposed as a way for people to increase their therapeutic time while engaged in enjoyable activities during their rehabilitation stay. This project will investigate if computing gaming, through the use of the OrbIT Gaming System, has benefits for people during their stroke rehabilitation. Particularly, we are interested in finding out if participation in computer gaming will improve movement and sensation in the affected upper limb following a stroke. The study will also ask participants and staff about their experiences using this system. This study is being conducted as part of a Physiotherapy student honours project. Participants are allocated (by chance) to one of two groups. Both groups will participate in the computer gaming activity using a novel controller and laptop, which will be readily available over a three-week period. The controller requires bimanual use – thus “forcing” the affected hand and arm to participate in directing motion of the unit. Further it is capable of delivering a haptic stimulation (vibration) to the affected hand only to theortically increase awareness of the affected hand. This will be used as an additional rehabilitation tool during each participant's stay at Hampstead Rehabilitation Centre, allowing as much use as possible. The games have been designed to be of broad appeal and easy to play (no experience required). Participants will also receive the usual rehabilitation ('standard care'). All participants (regardless of group) will be asked to undergo assessment at the beginning of the study and after the three-week period (1 hour for each assessment). All participants will be asked specific questions after the three-week intervention through a written questionnaire. This will enable us to compare the effects of computer gaming.

  • The AUSMED Heart Trial: The Australian Mediterranean diet trial for secondary prevention of heart disease

    This study is a multicentre, parallel design, randomised controlled trial, at La Trobe University using cardiology patients from two major Hospitals in Melbourne. The intervention will be 6 months in length with a follow up at 12 months. There will be two groups, the Mediterranean diet intervention arm versus the standard care diet (low fat, National Heart Foundation guidelines) control arm. The aim of this study is to determine whether the Mediterranean diet compared to standard diet intervention can prevent secondary cardiac events and improve cardiometabolic risk factors (lipid profile, inflammatory markers, metabolic parameters, anthropometry, body composition) in a multi-ethnic Australian population.

  • Can fish oil supplementation lead to cognitive enhancement in Type 2 Diabetes?

    Type 2 diabetes is linked with many complications such as heart disease, eye disease and kidney disease. People with Type 2 diabetes also have higher rates of diseases of the nervous system in the body including dementia and may have poorer memory and thinking ability compared to people without Type 2 Diabetes. Older people with Type 2 Diabetes are at higher risk for poorer brain function. Diet plays an important role in mental well-being and brain function as the brain needs nutrients found in foods to function well. Omega 3 fatty acids such as those found in fish oils, are found in the brain tissue in large amounts. Increasing dietary intake of fish oils can increase the amount of fish oils in the brain. The aim of this study is to determine if an increase in dietary fish oils can improve the function of the brain in older people with Type 2 diabetes. This pilot study will fill a gap as it is not known if an increase in dietary Omega 3 fatty acids can improve brain function in older people with type 2 diabetes. This is important as the number of older people with diabetes is increasing and currently there are no effective treatments for poor brain function. Eligible volunteers who participate in the study will be given a 6 month supply of fish oil or placebo capsules to take daily. Mental function will be measure by a verbal and computerized tests at the beginning, middle and end of the trial. A blood test, height, weight, and waist circumference will also be collected as well as information about the food you eat and drink at the beginning middle and end of the study. Neither you or the clinician conducting the research will know if you receive the fish oil or the placebo treatment, but a confidential record of which treatment you received will be kept by the chief investigator in the unlikely event you have an adverse reaction.

  • Building Bridges: Pilot Study of an Innovative Behavioural Family Intervention for Adolescents with Autism Spectrum Disorder.

    Building Bridges Triple P is a parenting program designed to help parents who have an adolescent with a developmental disability. The program aims to assist parents in their caring role and equip them with skills to address their adolescent’s emotional and behavioural problems. Building Bridges consists of four group and four individual telephone sessions, held over eight weeks. The program is open to all carers in the adolescent’s life. The program addresses a number of areas of concern for parents and an accredited Triple P facilitator will run the sessions. The groups will use a mix of discussion, practice and home based activities to address parenting practices, adolescent emotional and behavioural problems and symptoms associated with depression, anxiety and stress. Topics of discussion in the parenting group will include, understanding adolescents’ behaviour, encouraging independence in your adolescent, promoting positive family interactions, managing problematic behaviours, helping adolescents to manage their emotions and self care for carers. We are looking for carers of adolescents between the ages of 12 and 16, diagnosed with autism spectrum disorder. It is important that you are not participating in any parenting interventions at the same time. If you express interest in the program, you will be required to complete a short screening questionnaire over the phone. If you are eligible for the program, you will asked to attend the Curtin University Health and Wellness Clinic to complete a 90 minute interview. During the interview you will complete a booklet of questionnaires and you will be asked to complete the booklet of questionnaires again at two predetermined times following the Building Bridges program. The final booklet of questionnaires will be given to you three months after the parenting group has finished. Each booklet of questionnaires is estimated to take you approximately 60-90 minutes to complete. If you agree to participate, you will be required to attend four parenting group sessions at the Health and Wellness Centre at Curtin University. You will also be asked to complete four telephone sessions with the therapist at the same time as attending the parenting group. Other Triple P programs have demonstrated a variety of benefits for parents of teenagers and children with a disability, including improvements in child behaviours, positive parenting skills, parenting confidence, child relationships, and reduced parental stress. It is anticipated that Building Bridges will result in similar improvements. Results from the study are likely to improve the accessibility of the program to a wide range of parents that require positive parenting assistance.

  • A Phase II study: Haematopoietic Stem Cell Transplantation for highly active treatment resistant multiple sclerosis .

    Over the past 15 years a number of new treatments have proved successful in the treatment of multiple sclerosis. There a remains though a small group of patients who do not respond and who continue to have attacks despite treatment causing further permanent neurological disability in a cumulative fashion. This disability can take the form of muscle weakness, impairing walking ability, visual loss, impaired balance, bladder and bowel dysfunction and loss of higher intellectual faculties. Patients with aggressive forms of MS also have a shortened life span as a result of their disease. Haematopoietic stem cell transplantation (HSCT) is a procedure originally used to treat patients with blood cancers. A high dose of chemotherapy is given which not only kills the malignant cells but also normal healthy bone marrow and blood cells. In order for the patient to survive these cells must be replaced by giving the patient a stem cell infusion following the chemotherapy . The stem cells replenish the bone marrow and a new blood and immune system then grows from it. Over the last 15 years, HSCT has become much safer. At the same time, numerous lines of evidence have emerged suggesting that a small number of patients with severe autoimmune diseases such as MS not controlled by other treatments could also respond to treatment with HSCT. This evidence came initially from patients with a co-existent auto-immune disease (AID) including multiple sclerosis (MS) who had chemotherapy for blood tumours. It was observed that not only did their cancers remain in prolonged remission after HSCT but so did the manifestations of their autoimmune disease. The procedure requires an initial dose of chemotherapy with a drug called cyclophosphamide to help stem cells to be collected via a vein in the arm. Subsequently the patient is admitted into hospital tohave high doses of chemotherapy that intensely suppresses the immune system. At this point the stem cells collected at the earlier time point are reinfused through the vein so they can re-grow a new immune system and protect the patient from the toxic effects of the chemotherapy. It takes about 14 days for the new stem cells to grow and then follow up is conducted carefully over several years to see if this method of immunosuppression and immune reconstitution prevents the reemergence of multiple sclerosis. The procedure is not without risk with the major complications of infection and death. Overall the risk of death where the procedure is done for an autoimmune disease is quoted at between 1-5 %. The Neurology Unit at Austin Health has conducted trials in MS since 1996 and the Haematology Unit performs HSCT on a regular basis for patients with blood malignancies. The unit’s morbidity and mortality results for HSCT are on par with the world’s leading hospitals. We intend to explore therapy in patients with an aggressive form of MS and then follow them in a rigorous fashion over 5 years to gauge its effectiveness.

  • The Persistent Pelvic Pain (PPP) Study: Factors influencing the outcomes in women presenting with persistent pelvic pain

    AIMS: This study aims to clarify factors impacting upon outcomes in women presenting with persistent pelvic pain (PPP). The study team are keen to understand whether there are specific features of the woman, including the type and severity of the pain, the duration of these symptoms, or her response to her pain, that might influence or predict her outcome and thus potentially allow selection of the most appropriate therapeutic approach for specific patient characteristics. METHODS: Pelvic pain is the most common indication for referral to the outpatient gynaecology clinic. Information regarding this study, including study information, consent, and questionnaires regarding symptoms, quality of life(QoL), pain catastrophisation scale(PCS), will be sent to patients at the same time as their appointment information. On arrival at their first appointment, the research assistant will approach the prospective participants to ensure that initial paperwork and questionnaires were received, and offer the opportunity for questions. If the patient agrees to participate and has not completed the questionnaires they will be encouraged to do so whilst waiting. Consent to access patient data from medical records will also be sought. All clinical decisions regarding management will be independent of study questionnaires. Clinicians, who with the patient, decide that surgery for the PPP is warranted, will be asked to complete a brief survey regarding the factors influencing this decision. Follow-up questionnaires at 6 monthly intervals will be sent (either electronic, utilising survey monkey, or in paper format with reply paid envelopes, depending on patient preference). The pilot study will conclude at a minimum of 36 months. Patient questionnaires will take 15-30minutes.

  • The RADICAL project: impact of three different diagnostic tests for patients presenting with chest pain.

    Patients with new onset chest pain, suggestive of angina pectoris, are at high risk of acute cardiac events including myocardial infarction and death. Chest pain remains one of the most common reasons for presentation to the emergency department and hospital admission. In 2013-14, 653,572 presentations to emergency departments within Australia were attributed to ‘circulatory system illness’, 9.4% of all emergency presentations. The majority of patients presenting to hospital with recent onset chest pain are ultimately found to have a non-cardiac cause for their symptoms, or no definite diagnosis is made. Others may have an acute coronary syndrome (ACS) and require urgent admission and treatment. Appropriate risk stratification and triaging of all patients with chest pain is therefore crucial. New onset chest pain remains a common clinical presentation. Establishing efficient clinical care pathways, such as a rapid access chest pain clinic (RACPC), may help to reduce unnecessary and costly presentations to emergency departments and hospital admissions. However, among patients with an intermediate pre-test likelihood it remains unclear as to which test is best to perform. This project aims to assess the impact of a RACPC and to better understand the role of currently recommended investigations, such as exercise treadmill tests, CT coronary angiography and myocardial perfusion scans, among patients who attend the clinic with an intermediate pre-test likelihood of significant coronary artery disease.

  • Ventilation strategies in anaesthetised cardiac surgical patients.

    Apnoeic oxygenation is the delivery of oxygen to the lungs without causing the lungs to inflate. Whereas, low tidal volume ventilation is the delivery of oxygen to the lungs that causes the lungs to partially inflate and deflate. Both are established anaesthetic techniques that have been used for over fifty years and are used routinely in many surgical procedures to allow easier access to different structures in the chest. During cardiac artery bypass graft surgery (open heart surgery to bypass blocked arteries of the heart), the most common artery used to bypass blocked arteries is the left internal mammary artery (LIMA). This artery is has been proven to be the best option for short and long term survival after cardiac surgery. This artery is 15-26cm long and runs straight down the left side of the breastbone. The use of apnoeic oxygenation and low tidal volume ventilation are used as routine techniques to allow safe surgical access of the LIMA. Currently, there are no studies comparing apnoeic oxygenation to a low tidal volume strategy in a cardiac setting. It is unknown what the effects of these techniques are on levels of oxygenation and carbon dioxide on the vessels in the lungs, or on the function of the heart. In this study, we aim to compare the usefulness and safety of apnoeic oxygenation to a low tidal volume ventilation technique during dissection of the left internal mammary artery. There will be no additional requirements of the participant or deviation from standard surgical and anaesthesia care except for the additional sampling of 8mL (approximately two teaspoons) of blood from an artery in the wrist. This will allow for the additional measurements of oxygen and carbon dioxide. This study will help us determine if one technique (apnoeic oxygenation or low tidal volume ventilation) is better than the other. If so, that technique could be adopted as standard of care in this setting for all patients. A total of 24 subjects will be included at the Austin Hospital.

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