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1. Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study

   Background

   The COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted....

   Christine FitzGerald, Aoife Vaughan-Witts, ... Rose Galvin in BMC Research Notes

   Article Open access 30 September 2023
   

2. General Overview of the Statistical Issues in Clinical Study Designs

   This chapter introduces statistical issues often encountered in confirmatory clinical studies in a typical setting - randomized trials with parallel...

   Jialu Zhang in The Quintessence of Basic and Clinical Research and Scientific Publishing

   Chapter 2023
   

3. The INFINITY study protocol: a retrospective cohort study on decision making and clinical impact of biomarker-driven precision oncology in routine clinical practice

   Background

   Precision oncology, defined as treatment of patients with targeted therapies matched to specific molecular alterations, has entered routine...

   Uwe M. Martens, Jan Schröder, ... Corinne Vannier in BMC Cancer

   Article Open access 13 June 2023

4. Clinical Pharmacokinetic Studies

   Drug efficacy and response are a function of drug concentration over time. In clinical pharmacokinetic studies, aspects of drug absorption,...

   Axel Steinstraesser, Roland Wesch, Annke Frick in Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

   Living reference work entry 2024
   

5. Phases of Clinical Trials

   Clinical trials are trials conducted on human subjects. Clinical trials of an investigational drug product (IDP) that are intended to support drug...

   Charu Gandotra in The Quintessence of Basic and Clinical Research and Scientific Publishing

   Chapter 2023
   

6. Common Clinical Trial Designs

   Clinical Trials are studies conducted for the purpose of assessing the effect of an intervention in a defined population, or to evaluate one or more...

   Rosalyn Adigun in The Quintessence of Basic and Clinical Research and Scientific Publishing

   Chapter 2023
   

7. Enabling endpoint development for interventional clinical trials in individuals with Angelman syndrome: a prospective, longitudinal, observational clinical study (FREESIAS)

   Background

   Angelman syndrome (AS) is a rare neurodevelopmental disorder characterized by the absence of a functional UBE3A gene, which causes...

   Jorrit Tjeertes, Carlos A. Bacino, ... Elizabeth Berry-Kravis in Journal of Neurodevelopmental Disorders

   Article Open access 26 July 2023
   

8. Biosimilars in Clinical Trials

   Clinical trials impose validation of safety and efficacy, and biosimilars have contributed large share to the pipeline of clinical trials. These...

   Pallavi M. Chaudhari, Pranav Shah, ... Bhagwat Patil in Biosimilars for Cancer Treatment

   Chapter 2024
   

9. Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 PET/CT for staging patients with ovarian cancer: study protocol for a prospective clinical trial

   Background

   [ ¹⁸ F]Fluorodeoxyglucose ([ ¹⁸ F]FDG) positron emission tomography (PET) is recommended during diagnostic work-up for ovarian cancer;...

   Morten Bentestuen, Morten Ladekarl, ... Helle D. Zacho in BMC Cancer

   Article Open access 07 June 2024
   

10. Elements of Clinical Trial Protocol Design

    Clinical trials are conducted for many reasons, including to determine whether a new drug is safe and effective for a therapeutic use. A clinical...

    Rekha Kambhampati, Kirtida Mistry in The Quintessence of Basic and Clinical Research and Scientific Publishing

    Chapter 2023
    

11. A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study)

    Background

    Minimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance...

    Naoki Ikenaga, Tadayoshi Hashimoto, ... Makoto Ueno in BMC Cancer

    Article Open access 19 February 2024
    

12. Clinical Manifestations of Hepatitis E

    The clinical manifestations of hepatitis E are similar to those of other types of viral hepatitis. While acute hepatitis E is usually self-limited,...

    Shaoli You, Bing Zhu, Shaojie **n in Hepatitis E Virus

    Chapter 2023
    

13. Extracellular Vesicle-Based Clinical Trials

    Small extracellular vesicles (sEVs), particularly those derived from stem cells, are considered a new therapeutic alternative for various diseases...

    **ngliang Fan, Shu-Bin Fang, Qing-Ling Fu in Extracellular Vesicles

    Chapter 2024
    

14. Toxico-clinical study of patients poisoned with household products; a two-year cross-sectional study

    Background

    Several studies worldwide have investigated household product poisoning. We conducted a toxico-clinical study on the two-year prevalence of...

    Nastaran Eizadi-Mood, Sahar Sadat Lalehzar, ... Rokhsareh Meamar in BMC Pharmacology and Toxicology

    Article Open access 29 December 2022
    

15. Design an Intervention Study

    Randomized controlled trials are commonly designed to compare the effectiveness of treatments in rheumatoid arthritis (RA). In a clinical trial...

    Jun Ishizaki, Hitoshi Hasegawa in Rheumatoid Arthritis

    Protocol 2024
    

16. Clinical spectrum of rare bone fragility disorders and response to bisphosphonate treatment: a retrospective study

    Osteogenesis Imperfecta (OI) is a clinically and genetically heterogeneous group of diseases characterized by brittle bones. Though genetic mutations...

    Maëlle Charpié, Perrine Brunelle, ... Valérie Cormier-Daire in European Journal of Human Genetics

    Article 26 June 2024
    

17. Screening and Clinical Verification of Extracellular Vesicle Biomarkers

    Extracellular vesicles (EVs), lipid bilayer-encapsulated membrane particles carrying proteins, lipids, nucleic acids, and sugars, are shed by most...

    Bo Li, Yiyao Huang, ... Lei Zheng in Extracellular Vesicles

    Chapter 2024
    

18. Colorectal cancer detected by liquid biopsy 2 years prior to clinical diagnosis in the HUNT study

    Background

    Colorectal cancer (CRC) is often diagnosed in advanced stages. Circulating tumour DNA (ctDNA) has been proposed as an early diagnostic...

    Siv S. Brenne, Poul Henning Madsen, ... Eivor A. Laugsand in British Journal of Cancer

    Article Open access 12 July 2023
    

19. Advanced Therapy Medicinal Products: Clinical, Non-clinical, and Quality Considerations

    Cell therapy, tissue engineering, and gene therapy products, together called “advanced therapy medicinal products” (ATMPs), represent a heterogeneous...

    Enrico Mastrobattista, Erik Doevendans, ... Karin Hoogendoorn in Pharmaceutical Biotechnology

    Chapter 2024
    

20. Randomized Clinical Trials

    Observational studies suffer from biases and confounding, which can never be completely eliminated. Whenever feasible and ethically appropriate, a...

    Walter R. Palmas in Pocket Evidence Based Medicine

    Chapter 2023