ANZCTR search results

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

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31382 results sorted by trial registration date.
  • Can Egg Allergic Kids Eat Baked Egg? The CAKE Study.

    Egg allergy is the most common food allergy in Australian children. Many children with egg allergy can tolerate baked products, but will fail an oral challenge to raw egg. The primary aim of this study is to determine whether allergy to raw egg is better resolved by regular consumption of baked egg (intervention group, baked egg exposure) compared with the standard practice of an egg free diet (control group, egg avoidance).

  • Does dietary fructose restriction improve cardio-metabolic health in obesity?

    Consumption of high fructose diets have been shown to contribute to the rising incidence of obesity worldwide. Increased fructose intake has been associated with many of the components of metabolic syndrome (insulin resistance, elevated waist circumference, dyslipidaemia, and hypertension), a precursor for the development of diabetes and heart disease. It is hypothesized that restricting dietary fructose intake results in reduced circulating blood lipid levels, increased satiety hormones and reduced inflammatory mediators and improved overall cardio-metabolic health.

  • ADding negative pRESSure to improve healING in obese women undergoing caesarean section (The DRESSING Trial)

    Obesity is a growing global public health problem in developed nations. It is estimated that half of all Australian women of childbearing age are overweight or obese. Obese pregnant women are more likely to deliver their babies by Caesarean Section and are also more likely to have complications such as Surgical Site Infections after Caesarean Section than non-obese women. Wounds that fail to heal may cause considerable distress to patients and negatively affect the physical, social, emotional and economic aspects of their life. Wound complications also add to the cost of health care. Negative Pressure Wound Therapy has been used to aid healing since it was first developed in the late 1990s. The treatment is based on a closed sealed system that produces negative pressure to the wound surface. The wound is covered and sealed with an occlusive dressing and suction tubes which are connected to a vacuum pump which provides intermittent or continuous suction. Negative Pressure Wound Therapy is being used more frequently as a way to prevent wound complications especially Surgical Site Infections, but it has not been well tested yet. This study will test the effectiveness of two different methods to dress surgical wounds following Caesarean Section. These include Negative Pressure Wound Therapy compared to current care (standard dressing). We are doing this research study to find out the best practice for preventing Surgical Site Infections in obese women. To do this, we need to study women with a Body Mass Index (BMI) greater than or equal to 30 for one month following their surgery, and closely monitor their surgical wound

  • Randomised controlled trial of pressure Irrigation of major surgical wounds

    Wound infections after major surgery on the abdomen are very common. About 20-30 % of patients undergoing major prolonged abdominal surgery experience some form of wound infection. Although most of these infections are minor and often able to be treated by a short period of antibiotics or by release of the infection from the wound by drainage, in some cases it can be very serious resulting in the need for further surgical treatment or prolonged medical and nursing care. Although there have been improvements in surgical techniques to reduce wound infections, there is still room for improvement, in particular after prolonged operations. The purpose of this project is to see if we can reduce the rate of wound infections, by irrigating wounds at the end of procedures using a wound irrigating device with 2 litres of saline. This has been shown to reduce wound infections after major orthopaedic operations, but has not been well tested for major abdominal wounds. Participants will be assigned to having their wounds irrigated with either a pulse irrigator device or having standard treatment of saline poured into the wounds. GROUP 1. (n=64) Pulsed Irrigation Group The Surgilav (Stryker (Registered Trademark) pulse irrigating device (psi <15) is used in this group for wound irrigation. Wounds are wound irrigated with 2 litres of sterile saline solution delivered by the pulse irrigator prior to a routine closure methods. GROUP 2 (n=64) Standard Irrigation Group Patients assigned to this group will have their wounds irrigated with sterile saline solution, poured slowly into the wound, with excess fluid removed at the end of the procedure with a pad in the usual manner. The skin is closed in the usual fashion. Recruiting Hospitals: Austin Health & Warringal Private Hospitals Clinical significance: Significant reductions in wound infections in patients undergoing prolonged major abdominal operations will have a major impact in improving overall outcomes and reducing costs both to patients and hospital.

  • The Assessment of New Radiation Oncology Technologies and Treatments Radiation Oncology Register Pilot

    The ANROTAT Radiation Oncology Register Pilot (ARORP) aims to assess the feasibility of using a practical system to collect accurate and complete treatment and outcome data for patients undergoing radiotherapy treatment for their cancer in the following indications: - Intermediate risk prostate cancer treated with IGRT or non­IGRT - Prostate Cancer ­ Post Prostatectomy treated with IMRT or 3DCRT - Nasopharynx Cancer treated with IMRT or 3DCRT - Anal Cancer treated with IMRT or 3DCRT DESIGN There are two main design components to the ARORP: 1. An observational study in which data are entered into ARORP from a cohort of patients who received radiotherapy treatment for the indications described above 2. A cross­sectional surveys of users of the ARORP at participating centres The opinions of ARORP users will be measured via an evaluation survey that asks for their rating (excellent, good, fair, or poor) of the system in terms of access, data entry, navigation, training, support, and overall ease of use. The proportion of users providing an overall rating of excellent or good will be calculated. Focus group discussions with ARORP users also will be performed at each centre to obtain qualitative feedback on the system (including such things as the burden on the staff collecting the data).

  • Assesment of New Radiation Oncology Technologies and Treatments

    The Department of Health and Ageing and the Radiation Oncology professions recognised that there was a need for the Medicare Benefits Schedule (MBS) to support appropriate new radiation oncology technologies and treatments as they become available, to ensure optimal patient care. The ANROTAT projects aim is to develop and test a generic research framework able to collect and generate information to assess the safety, clinical efficacy and cost effectiveness of new radiation therapy technologies and treatments. This framework will then be used to assess the safety, clinical efficacy and cost effectiveness of; a) Intensity Modulated Radiation Therapy (IMRT) vs Three-Dimensional Conformal Radiation Therapy (3DCRT) in prostate (post prostactomy), anal and nasopharyngeal cancer b) Image Guided Radiation Therapy (IGRT) vs non-IGRT in patient with intermediate risk prostate cancer Information will be collected on the participant’s treatment, individual experience and costs associated with their treatment, which will be used in comparing the existing and new types of radiation therapy treatment methods currently available in Australian Treatment Centres. It is hypothesised that the new technologies; - produce treatment plans with improved dosimetric properties shown through reduced toxicity without unacceptable loss of efficacy as compared to plans produced using conventional standards - have the potential to optimise tumour dose and improve tumour control without causing unacceptable levels of toxicity as compared to treatment using conventional standards. - are cost-effective compared to conventional standards The ultimate aim of the ANROTAT study is to make the most effective radiation therapy treatment methods available to all cancer patients in Australia. The ANROTAT project is a non-interventional prospective evaluation of clinical activity. It is therefore defined as a clinical audit rather than a clinical trial.

  • Evaluating Couple Relationship Education with Military Couples

    Couple Relationship Education (CRE) is a preventative intervention for couples in intimate relationships, aiming to teach couples the skills required to maintain a mutually satisfying relationship before small issues become larger problems causing conflict and distress. Although CRE programs have been shown to be effective with civilian couples, few studies have looked at the effectiveness of CRE programs with military personnel and their spouses. The current study will tailor an existing CRE program for civilian couples, Couple CARE, to address the relationship challenges that may arise as a result of the unique military lifestyle; namely, postings, routine separations and deployments. Couples will complete measures of relationship satisfaction, stability, communication and individual adjustment, both before and after participation in the program, and again at a six month follow-up. Their scores on these outcomes will be compared to those of a control group, to assess whether CRE has a positive impact on relationship outcomes for military couples.

  • Does progesterone support in luteal phase deficiency help subfertile couples achieve a pregnancy?

    This project aims to assess the effectiveness of progesterone as luteal phase support in unexplained subfertile women with a previously diagnosed luteal phase hormonal deficiency. All women will be instructed in a fertility awareness-based charting method (the Sympto-Thermal method). It is hypothesised that progesterone given as luteal phase support increases the likelihood of pregnancy in unexplained subfertile women with a recognised luteal phase hormonal defect.

  • Does monitoring fertile times of the menstrual cycle help subfertile couples achieve a pregnancy?

    This project will assess the effectiveness of a fertility awareness-based charting method in increasing the likelihood of pregnancy in a population with unexplained subfertility. It is hypothesised that the Sympto-Thermal Method increases the likelihood of pregnancy in the unexplained ovulating subfertile population.

  • The Direct Benefit of Neuropsychological Assessment with Feedback in Multiple Sclerosis

    Cognitive impairment is one of the most common symptoms in multiple sclerosis (MS), being objectively confirmed on neuropsychological assessment in at least 50% of patients. It can be functionally disabling, and has been shown to significantly impact on patients’ capacity to function in a most domains of life, including personal self-care, mental health and mood, relationships, social and leisure activities, rehabilitation, driving, and employment. Cognitive impairment can also impact upon families and caregivers. In particular, MS patient cognitive impairment has been found to be significantly associated with caregiver distress, quality of life, and caregiver strain. The rehabilitation of cognitive impairment in MS is still in its infancy, and although neuropsychological assessment is often described as the first step in the rehabilitation of cognitive impairment, it can also be a form of therapeutic intervention in its own right. However, research into the direct therapeutic benefit of neuropsychological assessment as a rehabilitative intervention in MS is very limited. So, using an RCT approach, the present study aims to investigate the direct psychological benefit of neuropsychological assessment with feedback in patients with MS and their main caregivers immediately following the feedback session and up to 10 weeks later. It is proposed that the intervention will lead to an increase in patient and caregiver knowledge of the patient’s cognitive strengths and weaknesses, to an improvement in the patient’s use of adaptive psychological strategies for coping with the health problems caused by MS, and to more positive caregiving outcomes for the caregiver.

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