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Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study
BackgroundThe COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted....
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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... -
The INFINITY study protocol: a retrospective cohort study on decision making and clinical impact of biomarker-driven precision oncology in routine clinical practice
BackgroundPrecision oncology, defined as treatment of patients with targeted therapies matched to specific molecular alterations, has entered routine...
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Clinical Pharmacokinetic Studies
Drug efficacy and response are a function of drug concentration over time. In clinical pharmacokinetic studies, aspects of drug absorption,... -
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... -
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... -
Enabling endpoint development for interventional clinical trials in individuals with Angelman syndrome: a prospective, longitudinal, observational clinical study (FREESIAS)
BackgroundAngelman syndrome (AS) is a rare neurodevelopmental disorder characterized by the absence of a functional UBE3A gene, which causes...
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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... -
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;...
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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... -
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,... -
Extracellular Vesicle-Based Clinical Trials
Small extracellular vesicles (sEVs), particularly those derived from stem cells, are considered a new therapeutic alternative for various diseases... -
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)
BackgroundMinimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance...
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Design an Intervention Study
Randomized controlled trials are commonly designed to compare the effectiveness of treatments in rheumatoid arthritis (RA). In a clinical trial... -
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...
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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... -
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... -
Randomized Clinical Trials
Observational studies suffer from biases and confounding, which can never be completely eliminated. Whenever feasible and ethically appropriate, a... -
Toxico-clinical study of patients poisoned with household products; a two-year cross-sectional study
BackgroundSeveral studies worldwide have investigated household product poisoning. We conducted a toxico-clinical study on the two-year prevalence of...
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Clinical and diagnostic characteristics of Hashimoto’s encephalopathy: a single-center, retrospective study
Background and purposeDiagnosing Hashimoto’s encephalopathy (HE) is challenging. In contrast to other types of autoimmune encephalitis, HE shows an...