ANZCTR search results

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

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32898 results sorted by trial registration date.
  • 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.

  • Cognitive changes after saline or Plasmalyte infusion in healthy volunteers: blinded, randomized cross-over trial

    Intravenous crytsalloid fluids are one of the mainstays of in-hospital patient treatment with fluid intervention being ubiquitous for surgical and critical care patients. Cognitive changes such as a perceived difficulty in abstract thinking or mental arithmetic has been reported in subjects exposed to a commonly prescribed crystalloid solution - Normal Saline (0.9%). The postulated mechanism for the altered cognition is unclear but could be a result of NS 0.9% induced hyperchloraemia or NS 0.9% induced acidaemia (normal anion gap metabolic acidosis) that frequently occurs following saline administration. No study has attempted to formally investigate cognitive changes after the administration of saline or other commonly administered crystalloid solutions. Plasmalyte solution is a frequently used crystalloid solution with similiar properties to saline. However it is a more physiological and balanced crystalloid solution compared to saline as it has a significantly lower chloride concentration and physiochemical profile similar to normal plasma. Study hypothesis: Is normal saline associated with greater cognitive changes than Plasmalyte in healthy volunteers?

  • A randomized, placebo controlled, double blind, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single escalating doses of SAN-300 when administered to healthy subjects and patients with rheumatoid arthritis

    Study C2011-0301 is the first study in man for SAN-300. SAN-300 is being developed for the treatment of rheumatoid arthritis. SAN-300 will be administered intravenously in 9 cohorts and subcutaneously in 3 cohorts. Approximately 66 healthy volunteers and approximately 8 patients with active rheumatoid arthritis will be enrolled to receive a single dose of SAN-300 or Placebo. Participation in the study is approximately 1 month, including dosing and follow-up visits. Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month.

  • Can depression be prevented by reducing insomnia? The Good Night Sleep Study

    This project investigates the efficacy of a novel internet-based insomnia treatment program (SHUTi) as a prevention tool for Major Depressive Disorder.

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