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Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Expand descriptionThis clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
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Study to Evaluate the Safety of Repatha® in Pregnancy
Expand descriptionTo evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months
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Cochlear Implant With Anti-Inflammatory Agent
Expand descriptionIn an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device. In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.
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A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Expand descriptionThis is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
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Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.
Expand descriptionThe main purpose of this study is to determine the safety and feasibility of weekly intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy or a combination therapy.
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Optimising Health in Type 1 Diabetes
Expand descriptionType 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management. The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.
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A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures
Expand descriptionPatients with medically refractory epilepsy will be treated by intracerebroventricular (ICV) delivery of valproate using an implantable drug pump system. The dose of valproate will be escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label evaluation period (non-blinded). .
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Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Expand descriptionThe purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.
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Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Expand descriptionA Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy. Part 4 of this study is currently enrolling.
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A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer
Expand descriptionThis study aims to show that brain metastases from Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancers are able to be controlled by local therapies, Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain Radiotherapy (WBRT).