ANZCTR search results

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

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31255 results sorted by trial registration date.
  • Efficacy of ProKera (Registered Trademark) in the management of persistent epithelial defects.

    The aim of this project is to assess the effectiveness of ProKera (registered trademark) in the treatment of corneal ulcers. The current treatment for non-healing corneal ulcers include lubricating eye drops/ointments, extended wear contact lenses, tarsorrhaphy and botulinum-induced ptosis. Amniotic membrane has also been shown to promote the healing of the corneal surface. However, it is not commercially available in Australia. This project will assess ProKera (registered trademark), which is a commercially available amniotic membrane. It is currently approved by the US Food and Drug Administration but not the Australian Therapeutic Goods Administration. Patients above the age of 18 who are attending the cornea clinic with severe chemical injuries or poorly healing corneal ulcers will be invited to participate. Information to be collected include ulcer size and time to healing, and any complications from using ProKera (registered trademark).

  • Randomised Controlled Trial to compare initiation of peritoneal dialysis at one or two weeks post radiological catheter insertion

    Dialysis is the artificial replacement of a patient’s non-functioning kidney which has been damaged due to medical disease. There are two main techniques, peritoneal dialysis (PD) and haemodialysis (HD). PD requires the insertion of a catheter into the patient’s abdomen prior to use. Historically this has been done surgically, however a new technique is for it to be inserted radiologically, which appears to have several benefits including decreased waiting times, inpatient admissions and hospital expenses. The main purpose of this trial is to determine the optimal time to use these catheters post radiological insertion which no study has previously investigated. The most appropriate time to initiate dialysis after radiological insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD) complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD) by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare surgically inserted catheters and their immediate or delayed use. The primary objective is to determine the safest and shortest time interval between radiological placement of a Tenckhoff catheter and starting PD. The goal is to compare initiation of PD at one and two weeks post radiological Tenckhoff catheter insertion. This will be done by measuring the incidence of PD complications in a period post PD commencement as well as the HD associated problems during the same period if bridging HD is performed. This is a randomised controlled trial of patients who will start PD after radiological insertion of a Tenckhoff catheter at Royal Brisbane and Women’s Hospital (RBWH) and who meet the inclusion criteria. The patients will be randomised to one of two treatment groups. Group 1 will start PD 7 +/-2 days after Tenckhoff catheter insertion and group 2 at 14 +/-2 days. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection) after initiation of PD.

  • Effectiveness of school group-based acceptance and commitment therapy for children with anxiety: a randomised controlled trial

    Acceptance and Commitment Therapy (ACT) is rapidly growing in its evidence base for treating a variety of psychological disorders, but it is in an early stage of research in children. At the Children's Hospital at Westmead, Department of Psychological Medicine, we have developed and evaluated the effectiveness of an ACT program (ProACTive) for children and young people with anxiety disorders in the world's first and largest randomised controlled trial in this area. Following its initial successful implementation and evaluation in a hospital clinic setting, this project aims to evaluate the feasibility and effectiveness of a school-delivered ACT program (ProACTive) for children and young people with anxiety disorders. The program aims to improve quality of life and to assist school students with an anxiety disorder to manage their symptoms so they don't have such a negative interference in their life. We plan to evaluate the program on a group -delivered basis in children aged 7-17 years (primary and high school versions). An RCT will be used to compare two groups (n=65 per group) who receive (1) ProACTive and 2) comparison wait list control group. Controls will be offered the program 10 weeks after recruitment and two assessments (see below) take place 10 weeks apart. The program runs 1 hour every week for 10 weeks and will be implemented by school counsellors trained in ProACTive. It involves learning skills (e.g. mindfulness, acceptance, distancing from thoughts/feelings/sensations, exposure therapy), to assist students manage their anxiety in such a way as they can get on with doing what's important and things they enjoy (i.e. leading a more rich, full and meaningful life). Parents will also be engaged in the program, but with less involvement, undergoing psychoeducation and skills training on 2 occasions: on initiation of treatment and exposure therapy sessions. Effectiveness To evaluate the effectiveness of the program, participants in the treatment group and their parents/guardian will be asked to complete some standardised questionnaires and a 30 minutes structured interview: (1) prior to (ii) immediately after and (iii) 6 months after participating in the program. These questionnaires will take approximately 20 minutes to complete and will assess students' level of anxiety, depressive mod symptoms and quality of life. Controls will be assessed on the same measures on 2 occasions 10 weeks apart, prior to receiving the same program. Feasibility School counsellors implementing the program will be asked to complete a feasibility questionnaire evaluating the ease of implementation and usefulness of resources The main aims are: 1) Evaluate the feasibility of implementing ProACTive in a school setting 2) Evaluate the effectiveness of delivering ProACTive in a school setting

  • Intensive Family Support Service: Implementation Outcomes Evaluation

    IFSS is a parenting support service that works with the whole family. IFSS is committed to working with families with children (0-12) who have come to the attention of child protection and have high and complex needs, and supporting them to access the appropriate specialist services, such as drug and alcohol, domestic violence and mental health services. IFSS works with families to ensure that by the end of their involvement with the service, children: are adequately supervised; have their basic physical needs met; have their health needs met; have their emotional and developmental needs met; and have their educational needs met. The proposed research will adopt an approach that extends beyond the measurement of outcomes to include consideration of process and implementation. It aims to address questions relating to: 1. REACH: Is the service reaching the target population? 2. IMPLEMENTATION: Is the service being delivered as planned? 3. IMPACT: Is the service achieving positive outcomes for children and families? The research will employ multiple methods to address the key evaluation questions in a mixed method design involving the collection and analysis of qualitative and quantitative data from and about families, IFSS provider agencies and staff working in those agencies. The research will adopt an approach that extends beyond the measurement of outcomes to include consideration of process and implementation. Process and implementation evaluations investigate the degree to which activities specified in an intervention’s description are implemented as planned.

  • Can’t Even Quit - A pilot randomised, controlled trial of of an mHealth intervention to promote smoking abstinence for Aboriginal and Torres Strait Islander people

    The trial will test whether a smartphone app, when combined with usual smoking cessation support services, will double smoking abstinence rates at 6 months for Aboriginal people trying to make a quit attempt. This study will be a pilot randomised controlled trial involving approximately 200 Aboriginal smokers. Data will be collected at baseline, 4 weeks and 6 months by a project officer who is blinded to group allocation. Eligible participants are consenting Aboriginal people (aged over 16 years), with access to an Android or iOS phone and who are willing to make a quit attempt in the next month.

  • The effects of combining omega-3, vitamin D and protein with exercise on cognition in older people

    The Protein, Omega-3 aNd vitamin D Exercise Research (PONDER) study is a randomised controlled trial which will investigate the effects of combining a structured exercise program with dietary supplements on cognition and muscle mass and function in people aged 60 -85 years. The PONDER study is being run by researchers from the Institute of Physical Activity and Nutrition (IPAN) at Deakin University in Burwood. People who take part in this research will be assigned to one of two exercise programs run in a community based gym. Participants will either receive a dietary supplement drink which contains a combination of protein, omega 3 fish oil and vitamin D, or a placebo. The exercise programs will be run for 6 months in community based gyms under the supervision of qualified trainers. Participants will be asked to attend Deakin University in Burwood on 4 occasions over 12 months to undergo cognitive and health testing and to visit a local pathology centre on 3 occasions for a blood test. Participants in this study will attend 2 x 60 min supervised exercise sessions per week at a local gym, for a period of six months and will be asked to consume a dietary supplement daily during this time.

  • An open-label pilot trial of N-acetyl cysteine treatment for body dysmorphic disorder

    The aim of this study is to investigate the efficacy and tolerability of NAC in BDD. There is a growing body of research pointing to NAC's possible effectiveness in treating a range of psychiatric conditions. In particular, accumulating evidence points to its probable efficacy in treating obsessive-compulsive and related disorders including obsessive-compulsive disorder, trichotillomania, compulsive nail-biting and pathological gambling. BDD, another obsessive-compulsive spectrum disorder, is an often-debilitating condition affecting up to 2.5% of the population. This study will investigate whether NAC holds any promise as a new treatment for BDD. Participants will undergo treatment with NAC, at a starting dose of 1g twice daily (total 2g per day). Response will be assessed every two weeks and dosage will be adjusted depending on response and tolerability of the NAC, up to a maximum daily dose of 3g. Change in BDD symptoms and other scores over time will be assessed relative to baseline.

  • Effect of Sublingual (under the tongue) Rosuvastatin/Crestor (cholesterol/statin medication) in reducing the side effects experienced in subjects with high cholesterol & a history of cardiovascular disease (heart attack, coronary artery disease) with a known statin intolerance.

    The purpose of the study is to determine if the daily administration of sublingual (under the tongue) Rosuvastatin (cholesterol drug) is effective in reducing cholesterol level and the side effects of muscle aches and or memory changes in subjects with coronary artery disease & cardiovascular risk factors who are not yet at optimal cholesterol levels.

  • Effect of ovarian stimulation on oocyte quality and embryonic aneuploidy: a prospective, randomised controlled trial

    Hypothesis: Controlled ovarian hyperstimulation using conventional ovarian stimulation leads to a lower proportion of euploid embryos per patient than using mild ovarian stimulation when tested using the gold standard of 24 chromosome screening at D5-D6 of development. Primary Objective: To determine and compare the mean proportion of oocytes that develop to provide euploid vitrified blastocysts per patient resulting from conventional vs low dose stimulation protocol. Secondary Objectives: Number of euploid vitrified blastocysts per patient, number of 2PN preembryos generated, total number of embryos surviving to D5-D6 and total number of blastocysts biopsied. Quality of the oocytes generated using conventional vs. low dose stimulation protocols using mtDNA copy number. OHSS resulting in hospitalisation. Incidence of dose adjustment or cycle cancellation.

  • INFORM: Improving Information and Communication for Migrants with Cancer

    Our team has recently completed two studies on the unmet needs, psychological morbidity, quality of life and patterns of care of 1483 people with cancer from Arabic, Greek and Chinese speaking backgrounds. Compared to English-speaking patients with cancer, patients from culturally and linguistically diverse (CALD) backgrounds had greater communication issues, unmet information needs and psychological distress. Without sound understanding and recall of information provided, patients cannot be actively involved in treatment decisions and provide informed consent to treatment. Our team has level I evidence which demonstrates that audio-recordings of consultations and question prompt lists (QPL) are highly effective in increasing recall and meeting information needs in English-speaking patients with cancer. This Phase II study will investigate whether this level I evidence can be used in applied to a CALD population. This study draws on the Medical Research Council (UK) framework for the development and evaluation of complex interventions.

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