ANZCTR search results

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

You can narrow down the results using the filters

31430 results sorted by trial registration date.
  • The effect of taping on pain and function in people with knee osteoarthritis.

    The purpose of this study is to investigate the effect of applying sports tape to the patella in OA knees and measure whether there is a decrease in pain, and or a change in the kinematics at the knee during a step descent task. The hypothesis is that taping the patella will improve a person’s functional control of their knee, thereby decreasing the pain experienced during the task.

  • Neonatal Core body temperature investigation

    Pilot observational study of 5 body temperature sites on critically ill neonates.

  • Ecstasy Check-Up: A multi-site trial of a brief intervention for ecstasy use

    Our long-term goal is to decrease ecstasy use in Australia by motivating ecstasy users, through brief and early information and discussion, to reduce their use through providing research based information and discussion. The objective of the proposed research is to evaluate a brief discussion based on motivational interviewing (Ecstasy Check-Up) for regular ecstasy users (1 session) compared with an educational control discussion, which involves provision of an informational booklet regarding the facts and fiction on ecstasy use. The primary hypothesis of the proposed study is that the one-session brief motivation interviewing discussion will be associated with lower levels of ecstasy use and dependence than the education only discussion. E Check Up sessions in which the specialist more strongly adheres to motivational interviewing principles are expected to have better outcomes. Additionally, our secondary hypothesis is that participants in the study will like and gain some positive aspects from both conditions, regardless if they have been assigned the research or the education discussion. The research is of benefit to participants as it offers an opportunity for them to manage their ecstasy use. This lifestyle change has many benefits including improvements in physical and mental health. This benefit, however, cannot be guaranteed; it is dependent on participants’ engagement with the discussion. At the baseline session, all participants will be assured that any information they provide will remain strictly confidential (within the limits of legal confidentiality and duty of care). After written informed consent is provided and all questions and concerns have been answered, the baseline assessment will occur. At one-, four-, and six-month follow-ups the research assistant will conduct face-to-face follow-ups with all participants using the measures collected at the baseline assessment. The outcome measures will be modified to assess the relevant durations at each visit. For example, the measures will assess the last 90 days during the baseline assessment, and the past 30-days at the one-month follow-up.

  • Screening and Treatment for Alcohol Related Trauma using Brief Interventions (START Brief Interventions) project

  • Pilot Study of Intraperitoneal Bevacizumab for the Palliation of Malignant Ascites

    Malignant ascites is a frequent complication of advanced cancer. It is most commonly associated with adenocarcinoma of the ovary, breast, colon, stomach and pancreas. Ascites has a significant impact on quality of life. Increasing abdominal pressure causes distressing symptoms such as abdominal discomfort, early satiety, nausea and vomiting, dyspnoea, impaired mobility and lethargy. In severe cases vomiting and bowel obstruction may occur. Approximately half of patients with malignant ascites present with ascites at the time of cancer diagnosis. For the other 50% of patients, ascites is a sign of progressive disease or treatment failure. Median survival for all tumour types after the diagnosis of malignant ascites is 20-25 weeks. If ascites is present at diagnosis systemic cancer therapy can provide early palliation, particularly for those with chemotherapy-sensitive tumours. However in end stage disease tumours are often refractory to cytotoxic chemotherapy and other management options must be considered. Current guidelines advocate repeat paracentesis, indwelling catheter placement or peritoneovenous shunting for symptom control in malignant ascites. However all of these treatments have significant limitations. Repeat paracentesis is most commonly performed, however this provides only short-term relief, necessitating repeat trips to hospital for further intervention. The average time to repeat paracentesis for patients with malignant ascites is 10-13 days. There is no evidence to support how long the drain should remain in place, whether the drain should be clamped to regulate output, whether intravenous fluids should be administered or whether vital signs should be regularly recorded. The alternatives to repeat paracentesis are less than ideal. In-dwelling catheters risk infection and dislodgement. Peritoneovenous shunting is an invasive procedure and is associated with potentially fatal complications. Vascular endothelial growth factor (VEGF) is a glycoprotein secreted by tumour cells. VEGF stimulates tumour angiogenesis and increases vascular permeability via interaction with tyrosine kinase receptors on the endothelium of both normal and tumour-induced blood vessels. Malignant pleural and ascitic fluid demonstrates markedly elevated VEGF concentrations, up to 60 fold higher than in matched serum. The role of VEGF on vascular permeability is thought to be central to the pathogenesis of malignant ascites. Preclinical studies have demonstrated the efficacy and safety of intraperitoneal inhibition of VEGF as therapy to prevent accumulation of ascites. Bevacizumab is a recombinant humanised monoclonal antibody that binds and inhibits the biological activity of VEGF. Intraperitoneal administration of bevacizumab may be the route of choice when the goal of treatment is to palliate malignant ascites. These patients are routinely managed with repeat paracentesis and intraperitoneal bevacizumab administration can be performed during this procedure. Intraperitoneal administration also has the benefit of directing therapy in to the peritoneal cavity where high VEGF concentrations promote fluid secretion. One pilot study and two case studies have reported the safety and efficacy of intraperitoneal administration of bevacizumab for the treatment of malignant ascites. Systemic administration of bevacizumab is usually well tolerated but has been associated with an increased risk increased risk of bowel perforation. This rare but serious complication occurs in 1-2% of patients. Risk factors have not been well defined but may include bowel implants, large tumour burden, prior radiotherapy, recent surgery and bowel obstruction. The mechanism of bevacizumab-associated bowel perforation is likely to be related to the anti-VEGF effects on bowel perfusion and/or tumour regression. Gastrointestinal perforation has not been described following intraperitoneal administration of bevacizumab. Other side effects of systemic treatment with bevacizumab include hypertension (3-14.8% Grade III/IV), venous and arterial thromboembolic events (0-3%), bleeding, proteinuria, delay in wound healing, and fistula formation. Our pilot study will evaluate the safety and efficacy of intraperitoneal administration of bevacizumab to prevent the recurrence of malignant ascites. Given the significant cost of bevacizumab, the aim of the study is to find lowest effective dose. As the published data suggests an average time to repeat paracentesis in malignant ascites is 10-13 days, our treatment would be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.

  • A randomised controlled trial of 'Wide Awake Parenting': A program for the management of parental fatigue.

    A efficacy trial of Wide Awake Parenting: A program for the management of parental fatigue in the postpartum Fatigue is reported to be one of the most common health concerns in the postnatal period, for both mothers and fathers (Ansara, Cohen, Gallop, Kung, & Shei, 2005; Glazener, Abdalla, & Stroud, 1995; Parks, Lenz, & Milligan, 1999). "Wide Awake Parenting" (WAP) is a psychologically informed, written resource for parents aimed to assist parents to manage fatigue and promote well-being in the early postpartum. A systematic cohort of 220 parents of a newborn infant aged between 0-4 months will be recruited from Maternal and Child Health Centres in a diverse range of Local Govt. Areas in Metropolitan Melbourne. The primary aim of this study is to assess the effectiveness of the Wide Awake Parenting Programme in reducing fatigue and improving well-being for parents. It is hypothesised that parents who receive the WAP intervention – either the WAP resources only (intervention group one), or with the addition of professionally-led enhanced support (intervention group two), will have reduced fatigue and improved well-being compared to parents who are receiving standard care (control group). The following parental outcomes will be assessed, using validated self-report, psychometric instruments, at baseline, two weeks and two-months post intervention: 1. Symptoms of fatigue 2. Parental mood, reduced symptoms of depression, confusion, anxiety and irritability 3. Improved parenting sense of competence 4. Reduced parenting stress

  • Clinical trial on the safety and effectiveness of Tissue Therapies extracellular matrix on healing of venous leg ulcers

    This is a multi-centre, clinical trial. A sample size of 40 participants is sought. Up to 58 participants will be recruited to account for an estimated drop out rate of 30%. The study will include patients who have chronic, hard-to-heal, venous leg ulcers and use the following treatment procedure: 1) Cleansing the wound bed using local practices, at dressing change, then topically applying VitroGro ECM and covering with a non-adherent wound dressing. 2) Securing the dressing to the wound with tubifast and compression bandaging Dressings will be changed and the treatment procedure will be repeated once per week for Cohort 1 and twice per week for Cohort 2 when clinical, planimetry and photographic assessments will be made. The effectiveness of the treatment procedure will be evaluated on the basis of a 12 week treatment period. In the case of a wound that has healed before the 12 week end point, the treatment period will be shortened. Additional dressing or bandage changes, outside of the scheduled clinic visits, will be also be documented. The primary end point will be the reduction of ulcer size, or numbers healed at the 12 week point. Secondary end points are; reduction of pain, exudate and smell, condition of wound bed and surrounding skin and patient tolerance to the treatment provided and cost effectiveness.

  • Evaluation of the efficacy of probiotic supplements on illness and immunity in healthy active individuals

    There is increasing interest in the use of nutritional supplements to improve health and wellbeing. Probiotics are proposed to boost immunity and reduce susceptibility to infection. Common infections, such as URTI, are a significant burden on the community. There is growing body of evidence that probiotic supplementation may reduce the prevalence of URTI and GI illness in the general population. Hypothesis: That a probiotic supplement will enhance immunity and ameliorate the heightened susceptibility to upper respiratory tract illness (URTI) and gastrointestinal tract illness in active well-trained community individuals.

  • Components of an Effective Early Supported Discharge Team For Stroke: A West Australian Perspective

    This study will evaluate an early supported discharge service for stroke using a recently compiled list of components identified by experts in stroke research. In order to understand the achievement or otherwise of these components, a mixed methods approach will be used involving secondary analysis of health service data and focus group discussions of early supported discharge service staff.

  • Randomised Controlled Trial of a Novel Cannabis Use Intervention Delivered by Telephone

    Aims To evaluate the efficacy of a telephone-based intervention consisting of four-sessions of motivational interviewing (MI) and cognitive behavioural therapy (CBT) designed to assist individuals to reduce their cannabis use and related problems. Design Random allocation to intervention or delayed treatment control with four- and 12-week follow-up assessments. Setting Counsellors from the Cannabis Information and Helpline (CIH), an Australian reactive telephone service, delivered the intervention to callers seeking treatment. Participants A total of 160 participants were recruited by the CIH, with 110 participants completing the final follow-up assessment (69% retention). Measurements Cannabis use, dependence and related problems, and other substance use, were assessed at baseline and follow-up. Findings Intervention participants reported greater reductions in dependence symptoms (p<0.001), and related problems (p<0.001) compared to control participants at both follow-up assessments. Compared to control, intervention participants reported greater confidence to reduce cannabis use (p=0.002), and in turn reported a greater percentage of abstinent days at twelve weeks (p=0.019). Conclusions The remote delivery of brief MI+CBT cannabis use interventions continues to show promise in assisting a wider audience of treatment seekers while achieving comparable treatment outcomes to those of face-to-face interventions in the short term.

Tags:
  • Finding clinical trials