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Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study
Expand descriptionVitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.
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Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
Expand descriptionApproximately 36 DLT-evaluable subjects will be enrolled in this study. The locations of the study will be in the United States, Australia, Europe and Switzerland. The goal of this study is to evaluate the safety of intrahepatic injection (directly into the liver) of talimogene laherparepvec in combination with intravenously administered atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver metastases.
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A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6
Expand descriptionThe purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and/or high-grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and/or B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) gene rearrangements (HGBL-DH/TH).
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A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
Expand descriptionThis 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.
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Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
Expand descriptionThis is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.
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Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis
Expand descriptionThe investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.
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Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Expand descriptionThe purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
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DNS-3379 vs. Placebo in Stroke Rehabilitation
Expand descriptionThis is a randomized, double-blind, placebo-controlled parallel group outpatient 42-day treatment study that will utilize standard stroke rehabilitation outcome measures to evaluate the effect of DNS-3379 on upper extremity motor recovery in subjects following ischemic stroke.
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Smart Touch Non-dispensing Handling Studies
Expand descriptionThis study is a randomized, contralateral, investigator-masked non-dispensing study, to investigate the microbial contamination rates on the back surface of two types of soft contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister packs versus conventional lens packaging after short-term placement on the eye, and to compare the microbial contamination rates of the worn contact lenses to those on the participants' hands/fingers used to conduct lens insertion.
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A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
Expand descriptionThe purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.