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Safety and efficacy trial of whey growth factor extract for oral mucositis
Expand descriptionTGR Biosciences has obtained the rights to a bioactive extract from milk named whey growth factor extract (WGFEA). Research on this product has included establishing a processing strategy to enrich the biologically active components in milk, characterising these components, and testing the biological activity of the material using in vitro and animal experimental models. A target symptom for treatment by the extract is chemotherapy induced mucositis. The damage to oral and gastrointestinal tissues from chemotherapy and radiation therapies is referred to as "mucositis" which is a painful and debilitating condition for which there is no available preventative treatment. With the advent of bone marrow or peripheral stem cell transplants to improve immune cell number, mucositis is now the limiting toxicity in patients receiving high-dose chemotherapy. The potential benefits of a successful preventative therapy for mucositis include reduced patient suffering, reduced cost of hospitalisation, an increased tolerance to higher dose chemotherapy and therefore more effective tumour treatment. WGFEA has been examined in two previous clinical trials including a Phase IA safety evaluation of the extract in healthy volunteers that demonstrated safety and tolerance in the form of mouthwash and slow dissolving mucoadhesive patch and a Phase IB trial that further demonstrated safety and tolerance of the mouthwash and also showed promising effects in decreasing the duration and severity of mucositis. As the next stage of this work, a Phase II study aims to further examine safety and efficacy. The trial will investigate the ability of the extract to reduce the severity of chemotherapy induced mouth ulcers and will also provide additional safety information about the product.
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The effects of a six week Stanford Model chronic disease self management program, a six week pulmonary rehabilitation program with/without weekly maintenance in chronic obstructive pulmonary disease
Expand descriptionThe project aims to investigate in a sample of people with chronic obstructive pulmonary disease the effects of a psychological intervention as compared to a pulmonary rehabilitation program and then; compare six weeks of rehabilitation with and without weekly maintenance and construct a model to identify candidates who benefit most from maintenance. The incremental cost effectiveness of the three interventions will then be evaluated.
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Exercise and childhood TBI study- pilot
Expand descriptionThe project received ethical approval from the Children's Hospital at Westmead Ethics Committee,
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The LoPeZ study
Expand descriptionThis phase II study plans to trial monthly zoledronic acid therapy in patients with PET-detected bone metastases from non-small cell lung cancer, to assess whether zoledronic acid therapy has anti-tumour effects on subsequent PET scans, delays complications related to bony metastases, or is associated with a prolongation of overall or progression-free survival. We plan to study this question in patients with metastatic disease not being immediately commenced on palliative chemotherapy.
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Albendazole (oral) phase I
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IBCSG 32-05 / BIG 1-05 - Chemotherapy Adjuvant Study for women at advanced age
Expand descriptionThe overall aim of the CASA study is to investigate the role of PLD as adjuvant chemotherapy for older postmenopausal women for whom chemotherapy is indicated, but standard regimens, derived from trials in younger women, are assumed to be too toxic or inconvenient.
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An oral killed non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with mild to moderate airways disease: Safety and efficacy study
Expand descriptionThe aim of this study is to determine whether an oral vaccine against non-typeable Haemophilus influenzae will reduce the number of episodes of acute bronchitis experienced by people with mild to moderate airway disease.
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SWOG 0230 / IBCSG 34-05
Expand descriptionThe trial is evaluating whether the LHRH analogue goserelin, which temporarily suppresses ovarian function, can prevent permanent ovarian failure after chemotherapy in premenopausal women with hormone receptor-negative breast cancer.
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An oral killed Non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with moderate to severe airways disease: Safety and efficacy study
Expand descriptionThis aim of this study is to determine whether an oral vaccine against non-typeable Haemophilus influenzae will reduce the number of episodes of acute bronchitis experienced by people with moderate to severe airway disease
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Methoxyflurane for cancer patients with incident pain receiving radiotherapy
Expand descriptionIntroduction/your consent You are invited to take part in this research project because you have pain related to cancer that requires radiotherapy. This research project is testing a new way of controlling pain especially during movement. The current standard treatment for movement pain includes morphine which is often not effective. This Participant Information Sheet tells you about the research project. It explains what is involved. This will help you decide if you want to take part in the research. Please read this Participant Information Sheet carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your local doctor. If you decide you want to take part in the research project, then you will be asked to sign the Consent Form. By signing it you are telling us that you: · Understand what you have read in the information sheet · Consent to taking part in the research project · Consent to the use of your personal and health information as described in the information sheet. You will be given a copy of this Participant Information Sheet and Consent Form to keep as a record. Purpose and Background Doctors are looking for better ways to treat pain caused by movement especially when being transported to and from the radiotherapy department as an inpatient. In this research project, the researchers will test whether giving the medication, methoxyflurane given by inhalation (through a device called a Penthrox Inhaler), is better than the current standard treatment. The standard treatment is an extra dose of morphine, or similar medication, given half an hour before being moved to the radiotherapy department. No study has been done comparing the two treatments. Methoxyflurane has been approved for use in Australia to relieve acute pain. It is used in many situations including ambulances, emergency departments, dentistry, obstetrics and in children. It provides effective pain relief with very few side effects. Therefore this is not an experimental drug.