ANZCTR search results

To assess whether the combination of fenofibrate and coenzyme Q improves vascualr health in diabetes

Allan-Herndon-Dudley Syndrome (AHDS) that is a rare condition that usually results in severe physical and mental impairment and for which no licensed treatment is available. The study aims to provide an experimental treatment for children with AHDS. It is proposed that the daily oral administration of a compound called 3-5,Diiodothyropropionic Acid (referred to as DITPA) be provided to children with AHDS as the experimental treatment. We hypothesise that DITPA will improve the symptoms and abnormal thyroid function associated with AHDS.

A sample of 40 subjects were equally divided into the test group (multifocal) and control group (single vision). Participants wore these lenses on a daily wear basis over a 3 year period.

This study aims to determine the safety and efficacy of three different anti-cancer treatments in patients with colorectal cancer which has not responded to chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have colorectal cancer which is metastatic (i.e. has spread) and which has not responded to prior chemotherapy treatment. Patients with this health history routinely have a test performed on their cancer cells for a mutation in a gene called KRAS. Participants must have the non-mutated ('wild-type') variant of the KRAS gene to be eligible, among other health related criteria. Trial details Participants in this trial will be randomly (by chance) allocated to one of three arms (groups). Participants in Arm A will receive the standard dose of a drug called Cetuximab, which will be administered weekly by intravenous infusion (i.e. by a needle into the vein). Participants in Arm B will undergo the same treatment with Cetuximab, but will also take daily Erlotinib via an oral tablet (or tablets). Participants in Arm C will receive high dose Cetuximab on a weekly basis. Participants will also have the option to participate in an additional skin management study looking at 2 skin treatment options that might reduce some of the skin side effects commonly experienced by patients receiving these kinds of anti-cancer therapy. Patients participating in the skin management component will be randomly allocated to either of the 2 options. All participants will be assessed on a regular basis for the duration of their treatment, then for at least 12 months afterwards to determine response to treatment, safety and quality of life. It is not certain how long treatment will continue, as it is planned to be given until either the cancer progresses, or makes you feel too sick, or you indicate that you no longer want to participate, or you decide with your study doctor that there is no benefit to continuing treatment.

Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over 4 years

It is not known when in the course of incurable cancer referral to a specialist palliative care service should optimally be made. It is hypothesised that early contact with palliative care services will improve patients' end of life experiences through better symptom control and quality of life; addressing patients' supportive care needs; reducing lines of chemotherapy, and reducing the likelihood of dying in the acute hospital setting.

This study involves treatment with a standard chemotherapy for melanoma in combination with immune therapy. Fotemustine is a chemotherapy drug that is approved for use in metastatic melanoma. It has been shown to produce responses in 15 % of patients. Other benefits include delaying the onset of metastases to the brain, with its major side effects including nausea and vomiting (generally well controlled with current anti-nausea treatments) and low blood counts that could lead to a risk of bleeding and/or infections. The main aim of the study is to determine the number of patients who respond to successive treatment with chemotherapy followed by vaccine therapy and Ipilimumab in patients with previously untreated stage IV metastatic melanoma. It is planned to include 50 patients with stage IV metastatic melanoma in this study over a 3 year period. Who is it for? You may be eligible for this study if you have metastatic stage IV metastatic melanoma, provide written informed consent , an ECOG performance status of 0, 1 or 2, are deemed by your physician to be able to safely undergo leukapheresis, are aged greater than or equal to 16 years, have a life expectancy estimated to be greater than 4 months, and are able to provide a tumour sample or an alternative source of tumour antigen – as arranged by your treating hospital or facility. Trial Details: There are two components to the immune therapy that the patients will receive. One is treatment with a vaccine comprised of the patients’ own Dendritic Cells (immune system boosters, also known as DC’s), treated in the laboratory with their own tumour (autologous melanoma), plus a number of agents known to help stimulate the immune system. Previous studies have shown response rates (meaning melanoma shrinkage) in 10-25 % of cases at best. The overall survival benefits have not been assessed in large numbers of patients. However in a small trial of 11 patients receiving vaccines similar to (but not identical to) the vaccine being used in this study, 3 remain alive 5 years after study enrolment. The second component of the immune therapy is an antibody (Ipilimumab) that unblocks the protective mechanisms that normally operate to prevent the immune system recognising and damaging one’s own body. With this protective mechanism in place, it is very difficult for vaccines to boost the immune system to recognise and kill the melanoma. Ipilimumab has been shown to prolong survival in patients with metastatic melanoma who have previously failed chemotherapy. Of patients previously treated with chemotherapy and then treated with Ipilimumab, 44% were still alive one year after starting Ipilimumab treatment. In comparison of the patients who did not receive Ipilimumab only 25% were still alive after one year. By combining a vaccine with Ipilimumab, it is expected that the boosted immune system (resulting from the vaccines) will not be prevented from recognising and killing the melanoma.

Handwriting performance is often impaired after a stroke. Although task-specific upper limb practice can improve outcomes, the effectiveness of adult handwriting retraining has not been investigated. The aim of this study is to test the feasibility of a 4-week retraining program to improve handwriting performance using a pilot randomised trial design. Concealed allocation, blinded assessors and intention to treat analysis will be used. A community sample of 20 people with stroke will be randomly allocated to receive either 4 weeks of tailored handwriting retraining with twice weekly coaching sessions at home, or usual care. Outcomes will be obtained by a blinded assessor at baseline, and 4 weeks and 3 months post-intervention.

The study will examine the possibility that dendritic cell immunotherapy might increase HCV-specific cell mediated immunity with a concomitant decrease in the viral load, or even viral clearance.