ANZCTR search results

The primary aim of the study to evaluate the effectiveness of MPD as a monotherapy and adjunctive antidepressant treatment in patients with melancholic depression who have failed orthodox antidepressant options. Key Hypotheses: 1. Those receiving MPD and an antidepressant will show superior responder and remission rates compared to those receiving an antidepressant only 2. Those receiving MPD monotherapy will show comparable remission and responder rates to those in Group 2 (a non-inferiority hypothesis). 3. Those receiving MPD will improve more rapidly than those on antidepressants only 4. Substantive side-effects and drop-out rates will be lowest for patients on MPD only.

This study is an observational study investigating the use of new tracer for Positron Emission Tomography (PET). This tracer is preferentially taken up by cells that undergo rapid proliferation. The study has two aims: to assess the feasibility of conducting a larger trial, and to assess the sensitivity and specificity of FLT PET. The target patient population is those with locoregionally advanced mucosal head and neck squamous cell carcinoma undergoing definitive chemoradiation. You may be eligible to join this study if you are aged 18 and over, and have a previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx - Stage III or IV (TNM staging). You must be suitable for definitive radiotherapy + concurrent systemic treatment. Further details on the inclusion criteria for this study can be found in the relevant section on this form. Trial details All participants in this trial will undergo their standard cancer treatment, but with the addition of 2 18Fluoro-L-Thymidine and Positron Emission Tomography (FLT-PET) scans at baseline and at week 3 of radiotherapy. This will involve injection of FLT (study tracer) with scan commencing 60 minutes later.

The broad aim of the project is to test the effectiveness of a new service program to be made available to mothers of young children. The unique feature of the program is that it will combine the skills of community nurses and web-based technology to enhance support for mothers of infants. Following the development of the new program, it's effectiveness will be tested in trial involving approximately 800 mothers and infants. Half of the mothers and infants will receive the combined program while the other half will receive routine care provided for by CaFHS. We will test whether the combined program achieves equivalent outcomes to that achieved by routine care. The outcomes this project will assess include levels of parenting self-efficacy, perceived support, maternal mental health, infant development and the quality of mother-infant attachment.

Those randomised to the intervention group will receive the services of a Mobile Rehabilitation team who will deliver rehabilitation services while the participant is admitted to the acute wards. Those randomised to the control group will have usual care. Both groups will be followed up by phone interview at 3 months for those with moderate injury and 6 months for those with severe injury to determine health outcomes.

This study in pregnant women with asthma investigates the maternal, infant and childhood outcomes following asthma treatment adjustment using FENO, compared to standardised usual care treatment adjustment.

The central aim of the study is to determine if Evoked Compound Action Potentials (ECAPs) can be recorded during Deep Brain Stimulation (DBS). During the DBS lead implant procedure, specialised stimulating and recording equipment will be connected to the lead. Routine stimulation will be applied to the implanted lead electrodes and neural responses (ECAPs) will be recorded from the adjacent electrodes. Measurement of the ECAP responses may provide information to improve the implant procedure and stimulation programming, and provide information on the mechanisms of DBS.

Traditionally patients presenting to hospital with a heart attack are hospitalized for at least 5-7 days to monitor for complications such as increasing shortness of breath, recurrence of chest pain and fast irregular heart rate and also to increase their medications and receive a basic understanding of future management of their chest pain. A randomized trial in Canada showed that early discharge from hospital for low risk heart attack patients was feasible and safe when combined with close nursing follow up at home. We propose to randomize low risk heart attack patients to early discharge (<72 hours) with hospital-in-the-home (HITH) nurses and doctors compared with conventional 4-5 day stay in hospital. The aims of this study are 1. To prove that an early discharge strategy is safe and acceptable to patients with no increase in deaths, adverse events or unexpected readmission to hospital 2. To evaluate the patients’ experience and quality of life in both groups using questionnaires. 3. To examine the cost effectiveness of early discharge from hospital to HITH versus conventional 4-5 day hospital stay. Patients presenting to Box Hill Hospital with a heart attack and have undergone coronary angiogram and are treated with either medical therapy such as medications or angioplasty and stent will be screened using validated tools to assess for low risk. They will then be randomized to either early discharge with HITH (intervention group) or conventional 4-5 day hospital stay (control group). About 300 hundred patients will be recruited for the trial. The intervention group will be discharged from hospital before 72 hours and followed up daily by HITH nurse for at least 3 days. In the first week they will be reviewed by the HITH consultant doctor at the Maroondah clinic. The control group will be discharged home according to standard care at day 4 or 5. The main outcomes to be measured are: all-cause death, readmission or re-presentation to hospital due to chest pain, recurrent heart attacks or heart failure, as well as procedural and non-cardiac complications related to the index event at 30 days. The information will be gathered via phone interviews and medical records. Health-related quality of life and patients’ experiences of in-patient care will be evaluated using validated questionnaires. A telephone call to all patients at 6 weeks and 3 months will remind them about completing the questionnaires, and include a brief interview regarding re-presentation to the hospital, readmission, compliance with medications, attendance at cardiac rehabilitation and smoking cessation. All information collected will remain confidential and be de-identified for research purposes. The cost-effectiveness (reduced length of stay) of the early discharge strategy will also be analysed.

This research has the overall aim of identifying strategies to facilitate the detection and early treatment of eating disorders and related mental health problems in adolescence. It is being implemented in two phases. Phase 1 aims to identify barriers to the detection and treatment of eating disorders and related mental health difficulties in adolescence, with reference to data from adolescents, parents and teachers. This phase involves online questionnaire completion. Phase 2 aims to evaluate the effectiveness of a school-based intervention designed to facilitate the early detection and treatment of eating disorders and related mental health difficulties. This second phase takes the form of a randomised controlled trial comparing a 5 month school-based intervention to a waitlist control group. The waitlits control group will receive the intervention after a 5 month waiting period.

The main aim of this Phase I study is to assess the safety and immune effects of using autologous peripheral blood T cells in GD2 positive patients with metastatic melanoma or refractory solid tumours. Patients who are BRAF positive will be given being treated with dabrafenib and trametinib. These inhibitors are proving to be effective in the up to 60% of malignant melanomas that are found to have a BRAF mutation. However, drug resistance is emerging and many patients relapse affirming the need for further treatment development. Who is this study for and who is it open to? This study is for patients with metastatic melanoma who are BRAF V600E/K/R/D positive or negative, or other GD2-positive malignancies. Those who are BRAF positive must be eligible to receive dabafenib and trametinib Patients who consent to the study will be asked permission to test their archived tissue for GD2 expression. If this test returns a positive result, the patient may then continue with the trial. What will the patients receive? BRAF positive patients will receive dabrafenib 150mg bd and trametinib 2mg od during the 3 week period in which the T-cell product is being prepared. Once produced, the T-cell product will be given as a single intravenous infusion at a dose relevant to the cohort that the patient has been assigned to. The patient will then be monitored as per the follow up schedule specified by the study protocol. For patients who are BRAF negative and not receiving dabrafenib or trametinib, they may potentially receive two further doses of the T-cell product.

Stroke is a major cause of disability in Australia, it affects over 50,000 people annually. Stroke survivors are at increased risk of health problems, particularly a second stroke. Many of the risk factors for a second stroke, such as smoking, poor diet and lack of physical activity could be reduced with increased awareness, education and support. We plan to conduct a longitudinal study to investigate physical activity levels and cardiovascular risk factors in the 2 years following discharge from therapy after first ever stroke. Participants will be reviewed at baseline and at 6, 12 and 24 months following this. They will answer questions around their medical history and health status, complete questionnaires, have physical measurements taken (for example, blood pressure and walking tests) and be given activity monitors to wear for 5 days. At the baseline, 12 and 24 month assessments they will also be asked to have a blood sample taken within the following week. We hope to identify relationships between physical activity, cardiovascular risk, physical function and fatigue levels. This study has not previously been undertaken and will provide essential information for clinicians, allowing them to target their interventions to specific risk factors and reduce risk of further stroke. If a link between physical activity and cardiovascular risk is demonstrated, a strong rationale will be provided for therapies that improve physical activity participation.