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  • Books  (2)
  • DD1-905
  • Medicine Research.
  • Cham :Springer International Publishing :  (2)
  • De Gruyter
  • München : Beck
  • 615  (2)
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  • Books  (2)
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  • 1
    Online Resource
    Online Resource
    Cham :Springer International Publishing :
    Keywords: Pharmacology. ; Medical sciences. ; Drug development. ; Medicine Research. ; Biology Research. ; Pharmaceutical chemistry. ; Biometry. ; Toxicology. ; Pharmacology. ; Preclinical Research. ; Biomedical Research. ; Pharmaceutics. ; Biostatistics. ; Medical Toxicology.
    Description / Table of Contents: Introduction-.What is a DMC?-. Is a DMC required?-. Who is On the DMC?-. What are the Legal and Ethical Aspects of DMC?-. How does the DMC work with SDAC and Sponsor and External Groups ? -- What Does a DMC Meeting Look Like -- What data is used for DMC outputs and who programs? -- What is Included in DMC Outputs? -- What does the DMC final DMC outputs look like and how is it delivered? -- What Types of Safety Outputs Does the DMC Receive? -- What types of efficacy outputs does the DMC receive? -- What types of other outputs does the DMC receive? -- What About In-Between DMC Meetings -- What types of formal interim analyses does the DMC review? -- What does the paperwork from meetings look like? -- How does the DMC assess risk-benefit for their decision making? -- What are some examples? -- Conclusions.
    Abstract: This book provides an overview of Data Monitoring Committees - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotech/pharma and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity. This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to smoothly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the implications of it are so great. This book provides the following: Thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation; Includes practical and hands-on information on DMC implementation; Discusses a wide range of clinical trial – by phase and therapeutic area.
    Type of Medium: Online Resource
    Pages: XII, 111 p. 1 illus. , online resource.
    Edition: 1st ed. 2023.
    ISBN: 9783031287602
    DDC: 615
    Language: English
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  • 2
    Keywords: Pharmacology. ; Human physiology. ; Biotechnology. ; Medicine Research. ; Biology Research. ; Pharmacology. ; Human Physiology. ; Biotechnology. ; Biomedical Research.
    Description / Table of Contents: The effect of curcumin supplementation on pulse wave velocity in patients with metabolic syndrome: A randomized, double-blind, placebo-controlled trial -- Role of Curcumin in Regulating Long Noncoding RNA Expression in Cancer -- The Effect of Curcumin Phytosome on the Treatment of Patients with Non-alcoholic Fatty Liver Disease: A Double-blind, Randomized, Placebo-Controlled Trial -- Protective effects of curcumin phytosomes against high-fat diet-induced atherosclerosis -- Intravenous Curcumin Mitigates Atherosclerosis Progression in Cholesterol-fed Rabbits -- Updated review on the role of curcumin in gastrointestinal cancers -- Curcumin can bind and interact with CRP: an in silico study -- Antifungal activities of curcumin and difluorinated curcumin against clinical dermatophyte isolates -- Therapeutic Effect of Curcumin in Women with Polycystic Ovary Syndrome Receiving Metformin: A Randomized Controlled Trial -- Effect of Curcumin on Severity of Functional Dyspepsia; a Triple Blinded Clinical Trial -- Possible mechanisms and special clinical considerations of curcumin supplementation in patients with COVID-19 -- Paving the road toward exploiting the therapeutic effects of ginsenosides: an emphasis on autophagy and endoplasmic reticulum stress -- Medicinal plants and phytochemicals regulating insulin resistance and glucose homeostasis in type 2 diabetic patients: A clinical review -- Plants with anti-addictive potential -- Use of Plant-Derived Natural Products in Sleep Disturbances -- The effects of nutraceuticals and herbal medicine on Candida albicans in oral candidiasis: a comprehensive review -- Pharmacological properties of the plant-derived natural products cannabinoids and implications for cardiovascular health -- Beneficial effects of plant-derived natural products on non-alcoholic fatty liver disease -- Crocin Improves Oxidative Stress in Testicular Tissues of Streptozotocin-Induced Diabetic Rats -- Beneficial Medicinal Plants for Memory and Cognitive Functions Based on Traditional Persian Medicine -- The use of medicinal plants for the treatment of alopecia in the Canon of Avicenna: an evidence-based review -- Ethnobotanical uses, phytochemistry and pharmacology of different Rheum species (Polygonaceae): A review -- Genus Rosa: A review of ethnobotany, phytochemistry and traditional aspects according to Islamic traditional medicine (ITM) -- Ethnobotany, Phytochemistry, traditional and modern uses of Actaea racemosa L. (Black cohosh): A review -- Ethnobotany, phytochemistry and pharmacological features of Centella asiatica: a comprehensive review -- Ethnomedicinal uses, phytochemistry and pharmacology of different Cichorium species (Asteraceae): A review -- Medicinal species of the genus Berberis: A review of their traditional and ethnomedicinal uses, phytochemistry and pharmacology -- Protective effects of intravenous magnesium sulfate in stroke patients receiving amiodarone: A randomized controlled trial -- In silico identification of novel interactions for FABP5 (Fatty Acid-Binding Protein 5) with nutraceuticals: Possible repurposing approach.
    Abstract: Medicinal plants and their derived products remain as an indispensable source of bioactive molecules that serve as either drug candidates or lead compounds for drug design and discovery. There are several advantages for plant-derived therapeutics including wide availability, diverse pharmacological actions and a generally good profile of safety and tolerability. Over the recent years, there have been numerous reports from clinical studies testifying to the efficacy and safety of medicinal plants and phytochemicals in ameliorating several human diseases. A plethora of basic studies has also unravelled molecular mechanisms underlying the health benefits of herbal medicines. Nevertheless, issues such as identification of bioactive ingredients, standardization of the products and drug interactions remain to be further studied. In this book, we aim to put together several chapters on the medicinal properties and pharmacological action of medicinal plants, plant species and phytochemicals. The goal of this contributed volume is to present a comprehensive collection on most important therapeutic aspects of plant-derived natural products and their molecular mechanisms of action.
    Type of Medium: Online Resource
    Pages: X, 603 p. 814 illus., 28 illus. in color. , online resource.
    Edition: 1st ed. 2021.
    ISBN: 9783030648725
    Series Statement: Advances in Experimental Medicine and Biology, 1308
    DDC: 615
    Language: English
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