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Promoting Optimal Outcomes in Mood through Psychosocial Therapies for cancer patients: a randomised trial
This study aims to evaluate the effectiveness of a brief psychosocial intervention in reducing depression and anxiety in patients with cancer. Who is it for? You can join this study if you are aged 18 years or more and have a diagnosis of cancer for which you are attending any of the participating clinical sites for treatment. Patients already receiving current specialised psychological treatments or taking antidepressant medication will not be eligible. Trial details Eligible patients who have mild to moderate depression/distress and/or risk factors for becoming depressed will undergo a maximum of 4 x 30 minute tailored psychosocial therapy sessions over a period of 4 weeks. The type of therapy will vary depending on the each patient's needs, examples of which include practical concerns (e.g. finances), family concerns (e.g. child care), emotional concerns (e.g. anxiety about chemotherapy) physical concerns (e.g. pain), and spiritual concerns (e.g. shame). The psychosocial therapy will be delivered by health professionals who have undergone special training. Patients with low distress or risk factors will receive a patient self-directed resource kit comprising materials demonstrated to be acceptable and effective for patients with cancer. Patients who have no distress and no risk factors for the development of depression will continue to receive usual medical treatment. Participants will complete questionnaires at baseline and 10 weeks to assess depression, anxiety, unmet needs, and quality of life.
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Short-term efficacy of neural mobilisation for patients with nerve-related neck and arm pain
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An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL).
This study looks at the effectiveness and safety of the chemotherapy drug Bendamustine in treating advanced slow-growing non-Hodgkin's lymphoma or mantle cell lymphoma. Who is it for? You may be able to join this study if you have advanced indolent non-Hodgkin's lymphoma or mantle cell lymphoma. Trial details Participants will be randomly divided into two groups. One group will receive a combination of the drugs Bendamustine and Rituximab (BR). The other will receive standard treatment with either Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP). The study aims to compare the efficacy and safety of the combination of Bendamustine and Rituximab (BR) to the current standard treatments.
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Improving lower limb function in patients with major muscular loss or denervation following resection of a sarcoma.
This study looks at how supervised exercise programs can help in rehabilitating people with a major loss of muscle or nerves following surgery for sarcoma. Who is it for? You can join this study if you are recovering from a major loss of muscles or nerves after surgery for sarcoma. Trial details Participants will take part in a 12 week supervised rehabilitation program with exercises, 3 times per week, for 1.5 hours. The opposite unaffected limb is not used in the exercise program, and is monitored for comparison. Five tools will be used to monitor the psychological and physiological wellbeing of patients. The ultimate goal is to restore function of the affected limb to 80% of the unaffected limb, The study aims to see how well exercise is tolerated, and how effective exercises are at increasing muscle strength and mobility, and also quality of life.
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Optimising the protein and energy content of human milk feeds to improve the growth of preterm infants - A Randomised Control Trial (RCT)
Preterm infants < 30 weeks gestation will be randomised to either receive targeted fortification of human milk based on measured macronutrient composition or routine fortification of human milk based on assumed macronutrient composition. Nutrition intakes, growth and body composition will be the outcome measures.
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The effect of food on the pharmacokinetcs, tolerability and pharmacodynamics of BNC210 in healthy male volunteers
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Detection of Myocardial Fibrosis by Cardiac Magnetic Resonance relaxometry
Fibrotic tissue may cause myocardial dysfunction and failure. So it’s important to establish a non invasive method to assess myocardial fibrosis. Cardiac MR relaxometry can quantify myocardial fibrosis using tagging, T2 star quantification, T1 mapping, first pass perfusion and delayed enhancement techniques. These results will correlate with the echocardiography methodology and myocardial biopsy findings. the aims of this study to determine a MRI relaxometry of normal myocardium and any Alteration of relaxation times for early fibrosis in hypertensive disease. also, To detect possible fibrosis of remote myocardium in patients with prior infarction by analysis of delayed enhancement images after injection of MRI contrast agent. The hypothesis of this study is that Magnetic Resonance relaxometry can assess and measure early diffuse fibrosis in hypertensive heart disease. the expected benefits from this study is Understanding the Tost effective clinical treatments will lead to improved health outcomes at lower cost. also, Early intervention is known to reduce the cost burden to the community and healthcare delivery system. in addition, Validation of non invasive methods of measuring early fibrotic changes in myocardium is essential to direct the clinical decision making
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CLEMENT Capecitabine-radiosensitizing Lutetium-177 octreotate endoradiotherapy management of endocrine neurogenic tumours Response and Toxicity Assessment
177Lu-Octreotate is synthesized from [DOTA,Tyr3]Octreotate labelled with 177LuCl3 (7.8 GBq) distributed by IBD (Baarle-Nassau, the Netherlands). Each patient receives an infusion of aminoacids (Baxter Synthamin) containing 11.6g lysine and 23g arginine/L at 250 ml/hr. Thirty minutes later the radiolabelled somatostatin analogue is co-infused via a side-line over 10-20 minutes. Routine antiemetic therapy is given in the form of Tropisetron (5mg) intravenous (IV) bolus and oral Lorazepam (2mg). The chemotherapy with oral Capecitabine 1650mg/m2 will be reduced to 1500mg/m2 (in line with the American Society of Clinical Oncology (ASCO) dosage), for 14 consecutive days, and commenced on the morning of radionuclide therapy. Cycles will repeated each 8 weeks at the time of each subsequent radionuclide infusion. Temozolomide will be introduced on a dose escalation schedule, in cohorts of 3 patients, commencing at 100mg/m2 for 5 days. A standard dose escalation trial design will be followed with 3 patients completing 2 cycles at the starting dose (100mg/m2) prior to escalation to 150mg/m2 in the next 3 patient cohort. The ultimate maximum dose will not exceed the 200mg/m2 safe level established in the ASCO protocol. In the absence of toxicity all subsequent patients will be treated at this level All of the previously monitoring, including weekly blood testing and 2 monthly scanning, will remain unchanged from the original CLEMENT protocol. Assessments: Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) will be performed at baseline and then at each new treatment cycle (8 weeks). Quantitative uptake of 177Lu-octreotate in the tumours will be measured by serial whole body imaging at 4, 24, 48 hours and 5 days and graded according to a 4 point visual scale.
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The effects of a physiotherapy program on pain and physical function in individuals with hip joint osteoarthritis.
This project primarily aims to investigate the efficacy of a physiotherapy program to treat hip joint osteoarthritis. Secondary aims are to assess changes in relevant musculoskeletal impairments with treatment, maintenance of treatment effects over 6 months and the cost-effectiveness of physiotherapy. Primary hypothesis: A 12-week multimodal physiotherapy program will result in significantly greater improvements in pain and physical function than sham physiotherapy immediately post-treatment in individuals with hip OA.
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A Randomised, Double-blind, Placebo-controlled Phase I Study to Determine the Safety and Efficacy of Recombinant Human B[beta] Defensin 2 (rHuB[beta]D2 cream) in the Treatment of Staphylococcus aureus and other Infections in the Skin of Patients with Atopic Dermatitis