ANZCTR search results

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

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31356 results sorted by trial registration date.
  • Do images of a personalized future body shape help with weight loss in overweight individuals? A randomized controlled study

    A parallel group randomised control trial to evaluate the impact of viewing images of a future slimmer self on efforts to lose weight.

  • Is a new type of socket joint of a hip prosthesis stable without the use of screws in patients undergoing total hip replacement?

    This randomised controlled trial aims to determine whether a tantalum trabecular metal acetabular component in a primary total hip replacement prosthesis can achieve adequate initial fixation without the use of screws. This study utilises radiostereometric analysis, the most sensitive radiographic technique available to measure acetabular component migration in vivo.

  • Web-based Cognitive Behavioural Therapy for Women With Postnatal Depression: A Comparison with Face-to-Face Therapy

    Every year, Postnatal Depression (PND) affects at least 40,000 women in Australia. It has serious consequences for maternal mental health and infant development. Poor uptake of clinic-based treatments suggests a Web-based treatment can play a major role in tackling this public health problem, particularly as an increasing number of women will be identified as depressed through the National Perinatal Depression Initiative. Major barriers to treatment include stigma; poor access; treatment costs, and scheduling trips outside of the home with a new baby. We have developed an interactive, Web-based treatment targeted to women with PND and now aim to evaluate its efficacy compared to traditional face-to-face cognitive behavioural therapy in a 3-group randomised controlled trial. The main aims are to: (a) evaluate the efficacy of the program with respect to the primary outcomes of depressive episode remission, and amelioration of depression and anxiety symptoms; and (b) to evaluate the efficacy of the MumMoodBooster program with respect to secondary outcomes including the putative CBT change mechanisms, perceived stress, and marital functioning. A total of 210 mothers will be recruited via our well-developed relationship with Maternal and Child Health Centres in Victoria. In addition, the study will be advertised widely, targeting rural women (Internet e.g. beyondblue, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, etc) will be contacted and encouraged to screen and/or refer women with suspected PND. Potential recruits will be screened with the Edinburgh Postnatal Depression Scale (EPDS) and those scoring 13-20, inclusive, on the EPDS will be considered for further involvement. Following referral, women will be contacted by a member of the research team to assess eligibility and explain the study or will complete pre-screening measures online. Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV (SCID). Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy). Following contact with women via phone, a Participant Information and Consent Form will be sent in the mail and potential participants will be asked to sign it and return it to the researchers. An alternative online pre-screening and consent process is also in place. A clinical assessment will then be completed by phone and participants will be asked to complete baseline, pre-treatment questionnaires by visiting the secure website. Women will then be randomised in a 1:1:1 ratio to Web-based or face-to-face CBT (n = 70 in each), or to treatment as usual (n = 70), using a pre-generated permuted blocks allocation schedule. Post-test data will be collected at 9 weeks post-enrolment and follow-up data at three months post-treatment.

  • A multicentre randomized control study of atrial fibrillation in heart failure (CAMERA-MRI)

    Heart failure (HF) is a common heart condition whereby the pumping capacity of the heart is significantly reduced. It is the end result of many conditions which weaken the heart muscle. Atrial fibrillation (AF) is a common electrical disturbance of the heart which results in rapid and irregular heart rates which may cause HF or significantly worsen pre-existing HF. Similarly, HF may cause AF which may then worsen the severity of HF. Catheter ablation of AF is a minimally invasive procedure (involving the use of specialized instruments through the groin to make a small burn in the area of the heart that is responsible for irregular heart rates) which can eliminate AF in many patients. However, in patients with AF and HF, it is currently difficult to identify those in whom the AF is causing or significantly contributing to the HF. Such patients may benefit from catheter ablation. Patients with HF display a unique pattern of scarring in the heart muscle capable of being detected by magnetic resonance imaging (MRI) (non-invasive scan of the heart). The amount of scarring in the heart muscle appears proportional to the degree of reversibility of HF. Thus in patients with AF and HF, we propose that MRI may help identify those patients whose HF is most likely to improve, or even completely reverse, following catheter ablation. In this way, catheter ablation may become a useful tool in the treatment of patients with AF and HF.

  • Investigation of efficacy of novel first aid treatments for envenomation from snake bite

    Each year over 100,000 people die of snake bite, some of whom are Australian. The current recommended first aid (applying a pressure bandage and immobilising the victim) can be very effective but this method of first aid is often not performed correctly. We are trying to identify simpler and more effective methods, and methods that might allow the victim to still walk to get help. The research will NOT use snakes or snakebites or snake venom! The aim is to measure how fast it takes for a simulated snake bite, “mock venom”, to reach the blood stream after an injection in the skin in the participants leg. comparisons will be made, on separate days, with different new methods of first aid (a pressure pad or a cold pack applied over the simulated bite site). A further aim will be to test to see if the pressure pad method still works when the participant walks slowly on a treadmill.

  • The use of tissue expanders for breast reconstruction – what you put in is not always what you get out! A Pilot study of Tissue Expander fill and final volumes

    The primary purpose of this study is to evaluate tissue expander fill and final volumes in women undergoing breast reconstruction. Who is it for? This study included women who underwent tissue expander/implant based breast reconstruction following mastectomy. The surgeries were conducted over a 6 month period in 2012. Trial details All participants in this study underwent breast reconstruction surgery with tissue expander. The tissue expander fill volume inserted at the time of first implant was compared to the final volume on removal of the tissue expander at the time of second stage reconstructions (about 3-4 months later). A discrepancy between these values affects the size of the second stage implant and thus the cosmetic outcome.

  • Treatment for depression among individuals with substance use disorder: The Activate Study

    Behavioural activation (BA) is a treatment that aims to activate clients in ways that increase rewarding experiences in their lives, thereby reducing symptoms and behaviours characteristic of depression. BA has the advantage of being more time efficient and less complex than most other treatments for depression. This study is a clinical trial of an innovative behavioural activation treatment for depression (BATD-R) modified for use among people in treatment for substance use disorder (Activate). The aim of the study is to determine the efficacy of Activate (delivered individually) among opioid replacement therapy (ORT) and residential rehabilitation clients. The primary hypotheses are 1) Participants who receive Activate will demonstrate greater reductions in depression symptoms compared to those who receive treatment as usual (TAU), 2) Participants who receive Activate will demonstrate greater reductions in drug use and drug dependence compared to those who receive TAU. The project will also assess the feasibility of implementing BATD-R with ORT and residential rehabilitation clients. This will be measured by treatment retention, client compliance, client satisfaction, and therapist competence. Treatment efficacy will be determined by analysing changes in three outcome measures over the study period: 1. Depression symptoms 2) Substance use 3) Mental health comorbidity

  • Consumption of fish oil and a Mediterranean influenced antioxidant diet on telomere length in older Australians: Adherence and feasibility from a pilot study

    Traditional risk markers of CVD include blood lipids, inflammatory markers, and endothelial function. However, shorter telomeres have recently been associated with increased levels of C-reactive protein, being overweight and obese, and increased odds for developing CHD, when measured in peripheral blood mononuclear cells. Anti-inflammatory dietary habits have been associated with increased telomere length. Specifically, a low fat, high antioxidant diet, with an emphasis on high fruit, vegetable, wholegrain and legume intake, increased telomerase activity; and a small four week intervention of consumption of a Mediterranean diet was found to decrease the percentage of cells with telomere shortening. The Mediterranean diet is high in polyphenols, phytochemicals, and monounsaturated fatty acids that confers antioxidative properties to reduce oxidative stress and inflammation to protect the heart. Recent studies have observed that specific aspects of the diet such as nuts and/or olive oil is protective towards cardiovascular health, and may thus be extracted and incorporated into the diets of other populations. Thus, the association between shorter telomeres and CVD risk factors, and anti-inflammatory diets with telomere biology, suggest that components of diets with anti-inflammatory properties may reduce CVD risk by preventing the loss of telomere length and increasing telomerase activity. To date, no study has compared the effects of fish oil supplementation or a Mediterranean influenced Antioxidant (MAx) diet on telomere length and telomerase activity in the Australian population. Furthermore, while the tolerance and acceptability of fish oil has been studied, acceptability of Mediterranean dietary aspects in an Australian population has not been investigated in a randomised controlled trial. Therefore, investigation into this area is essential to assessing the feasibility of introducing these foods to the population due to the cardiovascular benefits that they accrue. This pilot study aims to identify (1) the adherence to fish oil and a MAx diet in older Australians and thus feasibility of such dietary interventions, and (2) areas for improvement in study design to aid the development of a larger six month study with 210 participants, which will investigate the effects of these dietary interventions on telomere length and telomerase activity.

  • Effects of 8 weeks of aerobic or modified football training on skeletal muscle markers of mitochondrial functioning, systemic inflammation and glucose regulation

    The purpose of this study is to determine the chronic effects of a generic gym based exercise mode (cycle) in comparison to modified touch football on markers and signalling processes associated with the development of type II diabetes (T2DM) and cardiovascular disease (CVD). Additionally, the current study will assess changes involving, body composition, skeletal muscle glucose uptake, anti- and pro-inflammatory processes, and risk markers associated with T2DM and CVD.

  • The effects of an in-season rehabilitation program on patellar tendon pain in jumping athletes.

    Jumper’s knee (patellar tendinopathy) is often reported in jumping athletes like volleyball players, especially during the volleyball season. It is hard to relieve this pain in-season. In this study we will investigate the effects of two physiotherapy /rehabilitation exercise programs (isometric and isotonic exercises). It is hypothesized that both exercise programs will decrease the level of tendon pain in in-season jumping athletes with patellar tendinopathy.

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