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CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
Expand descriptionThe purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.
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A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials
Expand descriptionThis is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.
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A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
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Scaffold-guided Breast Surgery
Expand descriptionThe clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a resorbable frame to support this growth of cells. The scaffold will be resorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is resorbable and is similar to the substance used for sutures and stitches that are dissolvable or resorbable in the body. The substance used for the scaffold is already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.
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SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)
Expand descriptionThe study will be conducted in adult patients with Chemotherapy-induced Peripheral Neuropathy (CIPN) that has been persistent for at least 3 months following completion of chemotherapy. A total of 60 patients will be enrolled in equal numbers of a placebo group and two different SON-080 dose groups. Treatment period will be 12 weeks long and patients will be followed-up for an additional 12 weeks.
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TESTING -ON Post-Trial ObservatioNal Cohort Study
Expand descriptionThe primary aim of this study is to extend follow up of TESTING study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on End Stage Kidney Disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs other) and kidney function (eGFR above and below 60 mL/min/1.73m2).
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Study of Fordadistrogene Movaparvovec in Early Stage Duchenne Muscular Dystrophy
Expand descriptionThe study will evaluate the safety and dystrophin expression following gene therapy in boys with Duchenne Muscular Dystrophy (DMD). It is a single-arm, non-randomized, open-label study
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The DRAGON 2 Trial
Expand descriptionIn the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
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Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma
Expand descriptionThis study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).
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Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours
Expand descriptionThis is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced micro satellite-stable (MSS) colorectal cancer, or gastric or ovarian cancer. The study is run in 2 parts. Phase 1a is dose escalation IVX037 monotherapy and Phase 1b is IVX037 with checkpoint inhibitor, sintilimab.