Clinical Investigations on Medical Devices, after the New European Regulation (2017/745)
Authors: Salvatore Bianco | AKROS BioScience s.r.l., Piazza Aldo Moro 20/d, 00071 Pomezia (Rome), Italy | Alfredo Nunziata | Giacomo Pozzoli | AKROS BioScience s.r.l., Piazza Aldo Moro 20/d, 00071 Pomezia (Rome), Italy | Institute of Pharmacology, Catholic University School of Medicine, Largo F. Vito 1, 00168 Rome, Italy
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Model Based vs. Rule Based Designs in Phase I Dose Finding Clinical Trials
Authors: Yunfei Wang | Department of Epidemiology and Biostatistics, The George Washington University School of Medicine | Jichuan Wang | Center for Translational Science, Children’s National Health System, Washington, DC 20010-2970, USA | Department of Epidemiology and Biostatistics, The George Washington University School of Medicine; Center for Translational Science, Children’s National Health System, Washington, DC 20010-2970, USA
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Patient and Surgeon’s Concerns with Post-Mastectomy Nipple Reconstruction: An Alternative to Traditional Nipple Reconstruction
Authors: Gerald L. Klein | MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA | Roger Morgan | William Heim | Nicholas Pashos | MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA | BioAesthetics Corporation, 6 Davis Drive, Research Triangle Park, NC 27709, USA | BioAesthetics Corporation, 6 Davis Drive, Research Triangle Park, NC 27709, USA
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Potential Errors and Corrections in Early Phase Drug Development
Authors: Gerald L. Klein | MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA | Roger Morgan | MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA
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Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need
Authors: Nathalie Vives | Founder, IntCom Trials and Research, Avenue Nouvelle 78, Brussels, Belgium
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The Importance of an Unbiased Safety Review Board in Phase I Clinical Trials
Authors: Gerald L. Klein | Department of Pharmacology and Toxicology, The Brody School of Medicine, East Carolina University, Greenville, NC 27834, USA | Roger Morgan | Department of Pharmacology and Toxicology, The Brody School of Medicine, East Carolina University, Greenville, NC 27834, USA
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Role of Sound Enhancer Device in Teleconsultation
Authors: Shijina Koliyath | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Ravi K. Chittoria | Vinayak Chavan | Abhinav Aggarwal | Saurabh Gupta | Chirra L. Reddy | Padmalakshmi B. Mohan | Imran Pathan | Department of Plastic Surgery and Telemedicine, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery and Telemedicine, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India
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Cluster Randomized Controlled Trials: A Quick Update on Concepts and Types
Authors: Bolaji Emmanuel Egbewale | Department of Community Medicine, College of Health Sciences, Ladoke Akintola University of Technology, Osogbo, Nigeria
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The Case for Digital Pill Use in Clinical Trials
Authors: Gerald L. Klein | MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA
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How a Network Came Together to Manage a Large Research Program During the Pandemic
Authors: Tamara Friedman | Office of Research Administration, Hackensack Meridian Health, 40 Prospect St, Hackensack, NJ 07601, USA | Elli G. Paleoudis | Avery Freed | Susan Adler | Cheryl Fittizzi | Office of Research Administration, Hackensack Meridian Health, 40 Prospect St, Hackensack, NJ 07601, USA | Office of Research Administration, Hackensack Meridian Health, 40 Prospect St, Hackensack, NJ 07601, USA | Office of Research Administration, Hackensack Meridian Health, 40 Prospect St, Hackensack, NJ 07601, USA | Office of Research Administration, Hackensack Meridian Health, 40 Prospect St, Hackensack, NJ 07601, USA | Office of Research Administration, Hackensack Meridian Health, 40 Prospect St, Hackensack, NJ 07601, USA and Hackensack Meridian Health School of Medicine, 340 Kingsland St Ste 123, Nutley, NJ 07110, USA
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The Role of Negative Pressure Wound Therapy with Instillation and Dwell Time in the Preparation of Wound Bed
Authors: Nishad Kerakad | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Ravi K. Chittoria | Saurabh Gupta | Chirra L. Reddy | Padmalakshmi B. Mohan | Imran Pathan | Shijina Koliyath | Neljo Thomas | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
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Distribution and Conduct of Clinical Trials Involving Music Therapy: Registered Clinical Trials in the Last 15 Years
Authors: Keiko Yukawa | Department of Health Policy and Technology Assessment, National Institute of Public Health, Wako, Saitama 351-0197, Japan | Hitoshi Fuji | Hajime Sato | Department of Health Policy and Technology Assessment, National Institute of Public Health, Wako, Saitama 351-0197, Japan | Department of Health Policy and Technology Assessment, National Institute of Public Health, Wako, Saitama 351-0197, Japan
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Role of Bactiguard Infection Technology in Preventing Catheter-Associated Urinary Tract Infections
Authors: Shijina Koliyath | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Ravi K. Chittoria | Abhinav Aggarwal | Saurabh Gupta | Chirra L. Reddy | Padmalakshmi B. Mohan | Imran Pathan | Department of Plastic Surgery and Telemedicine, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery and Telemedicine, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India | Department of Plastic Surgery, JIPMER, Pondicherry 605006, India
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Role of Low-Level Laser Therapy as an Adjunct in the Management of Diabetic Ulcer
Authors: Shijina Koliyath | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Ravi K. Chittoria | Chirra L. Reddy | Padmalakshmi B. Mohan | Imran Pathan | Neljo Thomas | Nishad Kerakada | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
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Design and Statistical Methods for Handling Covariates Imbalance in Randomized Controlled Clinical Trials: Dilemmas Resolved
Authors: Bolaji E. Egbewale | Department of Community Medicine, College of Health Sciences, Ladoke Akintola University of Technology, Ogbomoso, Oyo State, Nigeria
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The Digital Stethoscope in Telemedicine: A Health Camp Study
Authors: Imran Pathan | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Ravi K. Chittoria | Saurabh Gupta | Chirra L. Reddy | Padmalakshmi B. Mohan | Shijina Koliyath | Nishad K | Mohamed Ishaq Z | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Department of Plastic Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India | Telemedicine Infrastructure and Network Administrator, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
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Beyond Placebo: Alternative Options to the Randomized Control Trial Design in Rare Disease Studies
Authors: Preethi Sriram | Clinical Research Professional, Morrisville, NC, USA
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Remote Consent Clinical Research
Authors: Preethi Sriram | Senior Site Relations Manager, Atox Bio, 1000 Park Forty Plaza, Suite 210, Durham, NC 27713, USA
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Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need
Authors: Nathalie Vives | Founder, IntCom Trials and Research, Avenue Nouvelle 78, Brussels, Belgium
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The Promise of Small Data for Telemedicine in Chronic Condition Management: A Real-World Case Series
Authors: Steven M. Schwartz | IndividuALLytics, Inc., Ann Arbor, MI, USA | Brigid Byrd | Helen Dempster | Tim Payne | IndividuALLytics, Inc., Ann Arbor, MI, USA | Karantis 360, Hook, Hampshire, UK | Karantis 360, Hook, Hampshire, UK
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