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"Lumbar canal stenosis merupakan penyebab utama disabilitas pasien. Selective Nerve Root Block (SNRB) pada area lumbar adalah salah satu metode terapi untuk mengatasi nyeri akibat radikulopati lumbar yang bertujuan mengurangi kebutuhan operasi. Ultrasonografi (USG) muncul sebagai alternatif dengan kelebihan seperti tanpa radiasi, mobilitas tinggi, kemampuan pencitraan jaringan lunak, dan penetrasi jarum real-time jika dibandinagkan menggunakan Floroskopi. Penelitian ini merupakan studi uji klinis acak non-inferiority tersamar tunggal yang dilakukan di 2 Rumah Sakit. 52 subjek penelitian yang terdiri dari 26 subjek yang dilakukan tindakan SNRB dengan panduan fluoroskopi dan 26 subjek yang dilakukan tindakan SNRB dengan panduan USG. Tidak ada perbedaan karakteristik dasar antara kedua kelompok berdasarkan usia, jenis kelamin, IMT, durasi gejala. level lumbar VAS, maupun ODI pre operasi (p > 0,05). Penelitian ini menunjukkan penurunan signifikan pada nilai VAS di kelompok floroskopi dan USG pada 30 menit, 2 minggu, dan 12 minggu setelah tindakan dibandingkan dengan baseline (p < 0,01). Kendati demikian, tidak ada perbedaan VAS dan ODI yang signifikan antara kedua metode panduan pada setiap titik waktu (p > 0,05). Tidak terdapat perbedaan dalam pengurangan nyeri radikular lumbal, skor ODI, dan kejadian komplikasi antara tindakan SNRB dengan panduan fluoroskopi maupun USG. Penggunaan panduan USG pada SNRB terbukti lebih efisien dengan durasi yang lebih singkat dan sama efektifnya dengan fluoroskopi.

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Lumbar canal stenosis is a leading cause of patient disability. Selective Nerve Root Block (SNRB) in the lumbar area is a therapeutic method aimed at alleviating pain from lumbar radiculopathy to reduce disability and surgical needs. SNRB typically employs fluoroscopy but has drawbacks such as radiation exposure. Ultrasonography (USG) has emerged as an alternative offering benefits. This was a randomized single-blind non-inferiority clinical trial conducted at 2 Hospitals. There were 52 subjects, with 26 undergoing SNRB with fluoroscopy guidance and 26 with USG guidance. No baseline characteristic differences were found between the groups in terms of age, gender, BMI, symptom duration, preoperative lumbar level VAS, or ODI (p > 0.05). The study demonstrated significant reductions in VAS scores in both fluoroscopy and USG groups at 30 minutes, 2 weeks, and 12 weeks post-procedure compared to baseline (p < 0.01). However, no significant differences in VAS and ODI were observed between the two guidance methods at any time point (p > 0.05). There was no difference in the reduction of lumbar radicular pain, ODI scores, and complication rates between SNRB procedures guided by fluoroscopy and USG. USG guidance in SNRB proves to be more efficient with shorter duration and equally effective as fluoroscopy."

"All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals."

"ExpDesign Studio facilitates more efficient clinical trial design. This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and adaptive clinical trial designs using ExpDesign Studio:* Covers both classical and adaptive clinical trial designs, monitoring, and analyses* Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs* Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples* Emphasizes applications, yet covers key mathematical formulations* Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more* Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. "

"This book focuses on new small molecule approaches to combat viral infections. The chapters describe the discovery and development from bench through the clinic of relatively recently-approved antiviral drugs and compounds in advanced clinical development. Organized by a virus (such as HIV, HCV, RSV, influenza, HBV and CMV) and written by top academic and industrial authorities in the field, the book provides a unique opportunity to study, understand and apply discovery and development principles and learning without the need for an individual to research, analyze and synthesize all immense sourcing references. Topics showcase challenges and solutions of issues encountered, offeringtremendous experience accumulated over many years of research that will be particularly useful to basic and bench scientists as well as clinicians as they continue discovering and developing new drugs and therapies."

"This book discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance."

"Getting involved in medical and biomedical research through necessity or personal choice can be a testing experience. Each step of the process brings its own challenges, from liaising with supervisors, to the lack of opportunities to promote completed research.This brand new How to provides a complete guide to the process: from the planning stages, to execution, write-up, preparation for the viva examination, and how to maximise the impact of your research. It ensures you get the most out of the experience, both in terms of personal development and academic achievement, and"

"The book introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. This second edition has been completely revised to include the latest advances in drug discovery, development, clinical trials, manufacturing, and regulatory processes. At the end of each chapter is a case study to provide more in-depth perspectives and current issues facing the pharmaceutical industry.Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. "

"The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early drug development : strategies and routes to first-in-human trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.This book about provides an invaluable guide to the earliest and most critical stages of drug development, getting promising new chemicals into humans quickly, effectively, and safely, to provide information of maximum benefit for critical decision making."