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Contemporary Clinical Trials Communications

Amy S Ruppert, Abigail B Shoben
To evaluate the overall success rate of a new drug, phase 1, 2, and 3 trials were simulated using eight toxicity and two non-decreasing efficacy profiles. Six phase 1 designs including the standard 3 + 3, CCD, BOIN, mTPI, mTPI-2, and CRM were considered with standard phase 2 and 3 designs. Based on our results, phase 1 design recommendations are provided when data informing the general shape of the dose-toxicity curve exist. If a large jump in toxicity between dose levels is expected, the standard 3 + 3 design is recommended; it more often recognized when the MTD was exceeded and had the highest overall success rates...
December 2018: Contemporary Clinical Trials Communications
Agnes Maria Ciplea, Stephanie Laeer, Bjoern Bengt Burckhardt
Background: Variability in pre-analytical procedures such as blood sampling, sample preparation and transport can substantially influence bioanalytical results and subsequently impair reliability of data gathered during clinical trials. Especially in vulnerable populations, all efforts should be made to facilitate high-quality data extraction excluding unnecessary or repeated intervention. Methods: The EU-funded LENA project (Labeling of Enalapril from Neonates up to Adolescents) included a feasibility study in its preparatory procedures prior to first-in-child studies...
December 2018: Contemporary Clinical Trials Communications
M Tracie Shea, Jennifer Lambert, Madhavi K Reddy, Candice Presseau, Elizabeth Sevin, Robert L Stout
Background: Problems with anger and aggression are highly prevalent in Veterans of multiple war eras, including the most recent conflicts in Afghanistan (Operation Enduring Freedom; OEF) and Iraq (Operation Iraqi Freedom; OIF). The consequences of these problems, such as increased rates of divorce, domestic violence, occupational instability, arrests and incarceration, are often devastating. Despite the seriousness of these problems, relatively little is known about effective treatments for anger in Veterans...
December 2018: Contemporary Clinical Trials Communications
Farhana Rizwan, Harun Ur Rashid, Saquiba Yesmine, Forhad Monjur, Tapan Kumar Chatterjee
Background: Stevia, Stevia rebaudiana (Bertoni), has become an important economic plant for its commercial use as a sweetener. Stevia plays a significant role in the healthcare practice of different cultures and in population. Previous animal and clinical studies demonstrated the efficacy of Stevia against chronic diseases like diabetes and hypertension. This study aimed to investigate the beneficial effect of Stevia in chronic kidney disease (CKD) patients after three (3) months of treatment along with the conventional antihypertensive and anti diabetic medications...
December 2018: Contemporary Clinical Trials Communications
Kimberly Noel, Shamuel Yagudayev, Catherine Messina, Elinor Schoenfeld, Wei Hou, Gerald Kelly
Introduction: Comprehensive transitions of care, reduce dangerous hospital readmissions. Telehealth offers promise, however few guidelines aid clinicians in introducing it in a feasible way while addressing the needs of a multi-comorbid population. Physician adoptability remains a significant barrier to the use of Telehealth due to data overload, concerns for disruptive workflows and uncertain practices. The methods proposed aid clinicians in implementing Telehealth training and research with limited resources to reach patients who need clinical surveillance most...
December 2018: Contemporary Clinical Trials Communications
Akihiro Hirakawa, Junichi Asano, Hiroyuki Sato, Satoshi Teramukai
In oncology, next generation sequencing and comprehensive genomic profiling have enabled the detailed classification of tumors using molecular biology. However, it is unrealistic to conduct phase I-III trials according to each sub-population based on patient molecular subtypes. Common protocols that assess the combination of several molecular markers and their targeted therapies by means of multiple sub-studies are required. These protocols are called "master protocols," and are drawing attention as a next-generation clinical trial design...
December 2018: Contemporary Clinical Trials Communications
Kerstin Kick, Robin Assfalg, Susanne Aydin, Susanne Bechtold-Dalla Pozza, Dominik Böcker, Sonja Braig, Melanie Bunk, Desiree Dunstheimer, Alevtina Durmashkina, Uwe Ermer, Antonia Gavazzeni, Eva-Maria Gerstl, Melanie Heinrich, Melanie Herbst, Yvonne Kriesen, Ursula Kuhnle-Krahl, Herbert Müller, Nicole Nellen-Hellmuth, Christian Ockert, Claudia Ramminger, Marina Sindichakis, Stefanie Tretter, Katharina Warncke, Peter Achenbach, Anette-G Ziegler, Verena S Hoffmann
Background: Although detection of children at high risk of developing type 1 diabetes and diagnosis of early stages is possible, up to now there exists no approved therapy to delay or prevent type 1 diabetes. Thus it is vital to develop evidence-based interventions. For this a sufficient number of trial participants is crucial but difficult to obtain especially in asymptomatic children. Aim: Identifying family characteristics that lead to or impede trial participation and analyze reasons stated by families for non-participation...
September 2018: Contemporary Clinical Trials Communications
Marius Mølsted Flege, Simon Francis Thomsen
Background: Sample size in research projects is estimated before initiation of the study to minimise type 1 and type 2 error, while keeping the study's financial cost and subject enrolment to a minimum. This study investigates project-specific factors potentially associated with correct estimation of sample size in study protocols. Methods: Examination of 189 non-commercially sponsored study protocols (84 randomised controlled trials (RCTs) and 105 non-RCT studies) submitted to the Scientific Ethics Committees of The Capitol Region of Denmark from 2013 to 2015...
September 2018: Contemporary Clinical Trials Communications
David B Fogel
Clinical trials are time consuming, expensive, and often burdensome on patients. Clinical trials can fail for many reasons. This survey reviews many of these reasons and offers insights on opportunities for improving the likelihood of creating and executing successful clinical trials. Literature from the past 30 years was reviewed for relevant data. Common patterns in reported successful trials are identified, including factors regarding the study site, study coordinator/investigator, and the effects on participating patients...
September 2018: Contemporary Clinical Trials Communications
Yi-Ching Lee, Chelsea Ward McIntosh, Flaura Winston, Thomas Power, Patty Huang, Santiago Ontañón, Avelino Gonzalez
The diagnosis of ADHD among teens and young adults has been associated with a higher likelihood of motor vehicle crashes. Some studies suggest a beneficial effect of ADHD medication but the exact efficacy is still being debated. Further, medication adherence, which is low in this age group, can further reduce effectiveness. Our long-term objective is to reduce unsafe driving among drivers with ADHD by detecting medication non-adherence through driver behavior modeling and monitoring. As a first step, we developed the described lab study protocol to obtain reliable driver behavior data that will then be used to design and train behavior models built through machine learning...
September 2018: Contemporary Clinical Trials Communications
D R Shelley, C Kyriakos, A Campo, Y Li, D Khalife, J Ostroff
Introduction: Our team conducted a cluster randomized controlled trial (DUET) that compared the effectiveness of three theory-driven, implementation strategies on dental provider adherence to tobacco dependence treatment guidelines (TDT). In this paper we describe the process of adapting the implementation strategies to the local context of participating dental public health clinics in New York City. Methods: Eighteen dental clinics were randomized to one of three study arms testing several implementation strategies: Current Best Practices (CBP) (i...
September 2018: Contemporary Clinical Trials Communications
Scarlett O Baird, Christopher Metts, Haley E Conroy, David Rosenfield, Jasper A J Smits
There is a surprising lack of disseminable, community-based interventions for veterans experiencing difficulties during the reintegration process from military to civilian life. Physical Activity and Community Engagement (PACE) is a program which combines routine vigorous-intensity exercise with community engagement. The program builds on emergent evidence supporting the benefits of routine vigorous-intensity exercise among and establishing social connection. Using a randomized controlled trial (N = 60), we will obtain feasibility data and initial effect sizes for the early effects of PACE on reintegration difficulties...
September 2018: Contemporary Clinical Trials Communications
Mohammad H Rahbar, MinJae Lee, Manouchehr Hessabi, Amirali Tahanan, Matthew A Brown, Thomas J Learch, Laura A Diekman, Michael H Weisman, John D Reveille
Ankylosing spondylitis (AS) is characterized by inflammation of the spine and sacroiliac joints causing pain and stiffness and, in some patients, ultimately new bone formation, and progressive joint ankyloses. The classical definition of AS is based on the modified New York (mNY) criteria. Limited data have been reported regarding data quality assurance procedure for multicenter or multisite prospective cohort of patients with AS. Since 2002, 1272 qualified AS patients have been enrolled from five sites (4 US sites and 1 Australian site) in the Prospective Study Of Ankylosing Spondylitis (PSOAS)...
September 2018: Contemporary Clinical Trials Communications
Carsten Sommer, Diego Zuccolin, Valdo Arnera, Nicole Schmitz, Pernilla Adolfsson, Nicoletta Colombo, Raphaelle Gilg, Bryan McDowell
Clinical trials are slow and costly, built around the research centers that study local participants. Building clinical trials around patients in their homes and community through remote visits and monitoring could enhance recruitment and increase convenience for participants. This study evaluated different trial settings, a decentralized arm via telemedicine center (virtual study conduct), a conventional arm via health clinic (onsite study conduct) and a mixed model arm. Acute low-back pain patients (20-65 years) were recruited to this non-interventional trial in Switzerland...
September 2018: Contemporary Clinical Trials Communications
Amy Bartlett, Stephen J Kolb, Allison Kingsley, Kathryn J Swoboda, Sandra P Reyna, Ai Sakonju, Basil T Darras, Richard Shell, Nancy Kuntz, Diana Castro, Susan T Iannaccone, Julie Parsons, Anne M Connolly, Claudia A Chiriboga, Craig McDonald, W Bryan Burnette, Klaus Werner, Mathula Thangarajh, Perry B Shieh, Erika Finanger, Christopher S Coffey, Jon W Yankey, Merit E Cudkowicz, Michelle M McGovern, D Elizabeth McNeil, W David Arnold, John T Kissel
Background/Aims: Recruitment and retention of research participants are challenging and critical components of successful clinical trials and natural history studies. Infants with spinal muscular atrophy (SMA) have been a particularly challenging population to study due to their fragile and complex medical issues, poor prognosis and, until 2016, a lack of effective therapies. Recruitment of healthy infants into clinical trials and natural history studies is also challenging and sometimes assumed to not be feasible...
September 2018: Contemporary Clinical Trials Communications
Kandi E Velarde, Jennifer M Romesser, Marcus R Johnson, Daniel O Clegg, Olga Efimova, Steven J Oostema, Jeffrey S Scehnet, Scott L DuVall, Grant D Huang
Background: Randomized clinical trials are the gold standard for evaluating healthcare interventions and, more generally, add to the medical knowledge related to the treatment, diagnosis and prevention of diseases and conditions. Recent literature continues to identify health informatics methods that can help improve study efficiency throughout the life cycle of a clinical trial. Electronic medical record (EMR) data provides a mechanism to facilitate clinical trial research during the study planning and execution phases, and ultimately, can be utilized to enhance recruitment...
September 2018: Contemporary Clinical Trials Communications
Abid Kazi, Alyse Fazzi, Nicolle M Krebs, Aimee J Merchlinski, Brenda Kline, Susan Veldheer, John P Richie, Jonathan Foulds, Tonya Lane, Eric C Donny, Joshua E Muscat
Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS...
September 2018: Contemporary Clinical Trials Communications
Chung-Wei Chang, Yu-Yun Hsu, Su-E Kuo, Ting-Wei Hou
Background: Body weight control is a significant issue to pregnant women. Overweight or underweight not only affects the normal growth of the fetus but also results in health impacts for pregnant women. Currently, some mobile applications which have released to stress how to achieve the purpose of weight control are not suitable for pregnant women. To design an appropriate mobile application of body weight control for pregnant women, a multidiscipline team collaborated. Objective: This study proposed a mobile application approach to assist women to maintain an ideal weight control during their pregnancy...
September 2018: Contemporary Clinical Trials Communications
Wolfgang Geidl, Judith Deprins, René Streber, Nina Rohrbach, Gorden Sudeck, Klaus Pfeifer
Background: The importance of physical activity and the orientation of exercise therapy in rehabilitation has changed for many chronic health conditions. Exercise therapy is the most applied therapy form within multidisciplinary rehabilitation programs for almost all chronic health conditions. Despite the scientifically discussed need to refine exercise therapy, there is relatively little knowledge of how exercise therapy is actually conducted. This study protocol describes the methodological procedure used in the project "Exercise therapy in medical rehabilitation: a survey at facility and practitioner level", which aims to take a national survey of exercise therapy in rehabilitation practice in Germany...
September 2018: Contemporary Clinical Trials Communications
Karen L Margolis, Suzanne E Mahady, Mark R Nelson, Diane G Ives, Suzanne Satterfield, Carlene Britt, Saifuddin Ekram, Jessica Lockery, Erin C Schwartz, Robyn L Woods, John J McNeil, Erica M Wood
Background: Bleeding is the major risk of aspirin treatment, especially in the elderly. A consensus definition for clinically significant bleeding (CSB) in aspirin primary prevention trials is lacking in the literature. Methods: This paper details the development, modification, application, and quality control of a definition for clinically significant bleeding in the ASPirin in Reducing Events in the Elderly (ASPREE) trial, a primary prevention trial of aspirin in 19,114 community-dwelling elderly men and women...
September 2018: Contemporary Clinical Trials Communications
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