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Contemporary Clinical Trials Communications

Patricia Markham Risica, Meghan McCarthy, Katherine Barry, Susan P Oliverio, Anne S De Groot
Purpose: and Objectives: The risk of diseases associated with Metabolic Syndrome (MetS) is higher for Hispanics living in the northeastern United States than for other racial and ethnic groups. Higher risk of diabetes, high blood lipids, obesity and limited access to continuity of care are all factors that also contribute to disproportionately poorer chronic disease outcomes for Hispanics. Intervention approach: This article describes the planning and implementation of, and evaluation plans for the Vida Sana Program (VSP), a community-based group intervention created to address the identified MetS risks by encouraging healthier diet and physical activity behaviors among a low-income, largely Spanish speaking, and literacy limited uninsured population...
December 2018: Contemporary Clinical Trials Communications
Aileen Y Chang, Rakhi Karwa, Naftali Busakhala, Sara L Fletcher, Edith C Tonui, Paul Wasike, Michael A Kohn, Fredrick Chite Asirwa, Samson K Kiprono, Toby Maurer, Suzanne Goodrich, Sonak D Pastakia
Background: HIV-associated Kaposi sarcoma (KS), among the most frequent cancers seen in sub-Saharan Africa, is associated with a high prevalence of lymphedema. Lymphedema causes progressive functional impairment marked by swelling, physical discomfort, disfiguring changes, skin hardening from fibrosis, poor wound healing, and recurrent skin infection. While compression therapy is considered a major component of lymphedema management, this intervention has never been evaluated in HIV-associated KS lymphedema...
December 2018: Contemporary Clinical Trials Communications
P Chalela, E Munoz, D Inupakutika, S Kaghyan, D Akopian, V Kaklamani, K Lathrop, A Ramirez
Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces recurrence rates and nearly halves the risk of death during the second decade after diagnosis. Despite the proven benefits, about 33% of women receiving EHT do not take their medication as prescribed. This causes an increase in the risk for recurrence and death. To promote adherence to EHT among breast cancer patients, this study will develop and pilot-test an intervention consisting of 1) a bilingual, culturally tailored, personalized, interactive smartphone application (app); and 2) support from a patient navigator...
December 2018: Contemporary Clinical Trials Communications
Melissa Kurtz Uveges, Dina George Lansey, Olive Mbah, Tamryn Gray, Lisa Sherden, Jennifer Wenzel
Background: To our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment. Methods: This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational materials (PEM) and needs assessment vs...
December 2018: Contemporary Clinical Trials Communications
Jean-Etienne Ricci, Eran Kalmanovich, Christelle Robert, Thierry Chevallier, Sylvain Aguilhon, Kamila Solecki, Mariama Akodad, Luc Cornillet, Camille Soullier, Guillaume Cayla, Benoit Lattuca, François Roubille
There are currently one million heart failure (HF) patients in France and the rate is progressively increases due to population aging. Acute decompensation of HF is the leading cause of hospitalization in people over 65 years of age with a 25% re-hospitalization rate in the first month. Expenses related to the management of HF in France in 2013 amounted to more than one billion euros, of which 65% were for hospitalizations alone. The management of acute decompensation is a challenge, due to the complexity of clinical and laboratory evaluation leading to therapeutic errors, which in turn leads to longer hospitalization, high early re-hospitalization and complications...
December 2018: Contemporary Clinical Trials Communications
Tristan Tham, Lauren Rahman, Peter Costantino
Acute otitis media (AOM) represents a significant disease burden in the pediatric population. Besides vaccinations, there are no robust measures of reducing incidence of AOM in this age-group. This is a randomized controlled clinical trial evaluating the efficacy of a non-invasive middle ear aeration device, the EarPopper device (EP). We aim to investigate the reduction of episodes AOM in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used...
December 2018: Contemporary Clinical Trials Communications
Inkyung Jung, Hee Jung Ko, Sun Young Rha, Chung Mo Nam
When designing a cancer clinical trial, it is usual to assume an exponential distribution for a time-to-event outcome such as overall survival (OS). OS is often expressed as the sum of progression-free survival (PFS) and survival post-progression (SPP), each of which is assumed to be exponentially distributed. Then, OS does not follow an exponential distribution any more but a gamma or hypo-exponential distribution. In this study, we derived a sample size calculation formula for comparing OS between two treatment arms using the log-rank test for OS following a gamma or hypo-exponential distribution...
December 2018: Contemporary Clinical Trials Communications
Melinda Wang, Maureen P Kohi
Background: Uterine artery embolization (UAE) is a minimally invasive technique well established for treating symptomatic uterine fibroids. However, the post-procedure recovery for UAE involves a notable inflammatory process in response to ischemia known as post-embolization syndrome (PES). PES encompasses transient leukocytosis, low-grade fever, and can result in readmission of up to 10% of patients. In surgical settings, multiple studies have demonstrated the efficacy of glucocorticoids in reducing inflammation and associated pain...
December 2018: Contemporary Clinical Trials Communications
Melinda S Bender, Bruce A Cooper, Elena Flowers, Raymond Ma, Shoshana Arai
Introduction: Filipino Americans are at higher risk for obesity and related Type 2 diabetes (T2D) compared to other Asian subgroups and non-Hispanic whites. Yet, there are limited research studies to reduce health disparities and improve health outcomes for Filipinos. Weight loss lifestyle intervention trials such as the Diabetes Prevention Program (DPP) can reduce obesity and T2D risks through physical activity and healthy eating. Methods: Thus, we conducted a pilot Fit&Trim (DPP-based) intervention study - a randomized controlled trial 3-month intervention augmented with mobile technology + 3-month maintenance follow-up with a waitlist control...
December 2018: Contemporary Clinical Trials Communications
Debra A Standiford, Nancy Morwessel, Franziska K Bishop, Joan M Thomas, Emily Smith, Jamie Crandell, Kimberly A Driscoll, Christine M Hunter, Jessica C Kichler, David M Maahs, Elizabeth J Mayer-Davis, Michael Seid
Introduction: The Flexible Lifestyle Empowering Change Study (FLEX) is a multi-site randomized controlled trial to test the efficacy of an adaptive behavioral intervention to promote self-management and improve glycemic control for adolescents with type 1 diabetes mellitus. A two-step recruitment process was used to optimize study retention by facilitating informed decision-making regarding participation. Methods: Those who expressed interest at first contact were given more detailed study information followed by telephone calls to the adolescents and their parents to answer questions and explore potential barriers to participation before making a decision regarding study enrollment...
December 2018: Contemporary Clinical Trials Communications
Celia P Kaplan, Adam Siegel, Yan Leykin, Nynikka R Palmer, Hala Borno, Jessica Bielenberg, Jennifer Livaudais-Toman, Charles Ryan, Eric J Small
Background: To address limitations in recruitment and enrollment of diverse, low-literacy patients into prostate cancer clinical trials, we evaluated the feasibility, acceptability, and efficacy of an English and Spanish, Internet-based, multilevel recruitment intervention. Methods: Intervention components included (1) a low-literacy, bilingual, automated, Internet-based clinical trial matching tool; (2) a bilingual nurse who assisted individuals with questions and enrollment; and (3) a targeted, Internet-based advertising campaign...
December 2018: Contemporary Clinical Trials Communications
Richard Vuijk, Pieter F A de Nijs, Mathijs Deen, Salvatore Vitale, Mirjam Simons-Sprong, Michiel W Hengeveld
Background: Interest in autism spectrum disorders (ASD) in adulthood is increasing. Although a person may be diagnosed with ASD, the diagnosis reveals little about the individual's temperament, character, and personality. Also, relatively little is known about the personality of adults with ASD. Method: A reanalysis of scores on the Temperament and Character Inventory (TCI) administered to a group of 66 normally intelligent men aged 18-63 years, diagnosed with ASD, by individual case matching to a comparison group of 66 men from the general population drawn from the TCI manual...
December 2018: Contemporary Clinical Trials Communications
Florent Schäfer, Jean-François Jeanne
In a context of rising interest in food and supplement clinical trials, operational considerations for the set-up and conduct of these research projects remain difficult to address in the absence of a harmonized referential. Food trials tend to be more pragmatic than drug trials which are usually more elucidatory. However, comparing them is difficult because the objectives they serve are different. Food trials are usually conducted to evaluate the effect of food products on the prevention or mitigation of symptoms, not the treatment or cure of a condition...
December 2018: 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
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