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Contemporary Clinical Trials Communications

Andrew J Cole, Reginald W Johnson, Leonard E Egede, Prabhakar K Baliga, David J Taber
There is a lack of data analyzing the influence of cardiovascular disease (CVD) risk factor control on graft survival disparities in African-American kidney transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in African-Americans, leading to higher rates of renal failure and major acute cardiovascular events. However, with the exception of hypertension, there is no data demonstrating similar results within transplant recipients. Recent analyses conducted by our investigator group indicate that CVD risk factors, especially diabetes, are poorly controlled in African-American recipients, which likely impacts graft loss...
March 2018: Contemporary Clinical Trials Communications
Mark W Vander Weg, Mace Coday, Michelle B Stockton, Barbara McClanahan, George Relyea, Mary C Read, Nancy Wilson, Stephanie Connelly, Phyllis Richey, Karen C Johnson, Kenneth D Ward
Despite advances in behavioral and pharmacological treatment for tobacco use and dependence, quit rates remain suboptimal. Increasing physical activity has shown some promise as a strategy for improving cessation outcomes. However, initial efficacy studies focused on intensive, highly structured exercise programs that may not be applicable to the general population of smokers. We describe the rationale and study design and report baseline participant characteristics from the Lifestyle Enhancement Program (LEAP), a two-group, randomized controlled trial...
March 2018: Contemporary Clinical Trials Communications
Brandy Stoffel, Christine Sorkness, Carol Pech
In 2014, the Request for Applications from the National Institutes of Health (NIH) for continued funding of a multi-site clinical and mechanistic research network, Inner City Asthma Consortium (ICAC), called for "efficient IRB review and approval for multi-center studies" and "IRB approval within 30 days from submission". These requirements were precursors to the NIH policy of single IRB review for multi-site studies. Here we share our challenges, implementation processes, results, and recommendations, using a single, independent IRB...
December 2017: Contemporary Clinical Trials Communications
Dori Pekmezi, Cole Ainsworth, Taylor Holly, Victoria Williams, Tanya Benitez, Kaiying Wang, Laura Q Rogers, Bess Marcus, Wendy Demark-Wahnefried
Telephone-delivered interventions do not require frequent clinic visits, literacy, or costly technology and thus may represent promising approaches to promoting physical activity in the Deep South, a largely rural U.S. region, with generally lower physical activity, income, and education levels. Building on past Interactive Voice Response (IVR) system-based HIV studies and extensive formative research (11 focus groups on physical activity intervention needs/preferences in the Deep South), the resulting IVR-supported physical activity intervention is now being tested in a randomized controlled trial with a waitlist control...
December 2017: Contemporary Clinical Trials Communications
Elizabeth Flood-Grady, Virginia C Clark, Angie Bauer, Lauren Morelli, Patrick Horne, Janice L Krieger, David R Nelson
Introduction: Although registries can rapidly identify clinical study participants, it is unknown which follow up methods for recruiting are most effective. Our goal is to examine the efficacy of three communication strategies for recruiting and enrolling patients who were identified via a contact registry (i.e., registry linked to a consent to re-contact program). Methods: Patients who met the study criteria were identified via the contact registry and targeted for recruitment...
December 2017: Contemporary Clinical Trials Communications
Diane M Flynn, Linda H Eaton, Honor McQuinn, Ashley Alden, Alexa R Meins, Tessa Rue, David J Tauben, Ardith Z Doorenbos
Chronic pain is a significant problem among military personnel and a priority of the military health system. The U.S. Army Surgeon General's Pain Management Task Force recommends using telehealth capabilities to enhance pain management. This article describes the development and evaluation of a telehealth intervention (TelePain) designed to improve access to pain specialist consultation in the military health system. The study uses a wait-list controlled clinical trial to test: 1) effectiveness of the intervention, and 2) interviews to assess barriers and facilitators of the intervention implementation...
December 2017: Contemporary Clinical Trials Communications
Julene K Johnson, Steven E Gregorich, Michael Acree, Anna M Nápoles, Jason D Flatt, Dana Pounds, Alexandria Pabst, Anita L Stewart
Objective: To describe the recruitment and baseline results of the Community of Voices study that aims to examine the effect of a community choir intervention on the health and well-being of older adults from diverse racial/ethnic and socioeconomic backgrounds. Method: Using community-based participatory research methods, we recruited adults age 60 and over from 12 Administration on Aging-supported senior centers in San Francisco into a 2-arm cluster-randomized controlled trial of the community choir intervention...
December 2017: Contemporary Clinical Trials Communications
Binita Shah, Lisa Ganguzza, James Slater, Jonathan D Newman, Nicole Allen, Edward Fisher, John Larigakis, Francisco Ujueta, Eugenia Gianos, Yu Guo, Kathleen Woolf
Background: Multiple studies demonstrate the benefit of a vegan diet on cardiovascular risk factors when compared to no intervention or usual dietary patterns. The aim of this study is to evaluate the effect of a vegan diet versus the American Heart Association (AHA)-recommended diet on inflammatory and glucometabolic profiles in patients with angiographically defined coronary artery disease (CAD). Study Design: This study is a randomized, open label, blinded end-point trial of 100 patients with CAD as defined by ≥50% diameter stenosis in a coronary artery ≥2 mm in diameter on invasive angiography...
December 2017: Contemporary Clinical Trials Communications
Crispin Day, Jackie Briskman, Mike J Crawford, Lucy Harris, Paul McCrone, Mary McMurran, Paul Moran, Lou Morgan, Stephen Scott, Daniel Stahl, Paul Ramchandani, Timothy Weaver
The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks...
December 2017: Contemporary Clinical Trials Communications
Sarah T Stahl, James Emanuel, Steven M Albert, Mary Amanda Dew, Richard Schulz, Gregg Robbins-Welty, Charles F Reynolds
Introduction: Experiencing the death of a spouse during late life is associated with an increased risk of developing debilitating mental health problems. Healthy lifestyle practices, such as regular exercise, healthy eating, and good sleep hygiene are promising strategies to influence the mental health and associated physical symptoms of late-life spousal bereavement. Objective: This paper describes the design and rationale of an intervention development study addressing selective and indicated prevention of depression, anxiety, and/or complicated grief disorder(s) among adults 60 years and older who are grieving the recent loss (within 8 months) of a spouse or partner...
December 2017: Contemporary Clinical Trials Communications
Jessica Lynn Stewart, Gina B Besenyi, Lovoria B Williams, Victoria Burt, Judith C Anglin, Sharad A Ghamande, Steven Scott Coughlin
BACKGROUND: Cancer of the uterine corpus is the most common gynecologic malignancy and the fourth most common cancer in U.S. women. There is a racial disparity in the survival from endometrial cancer and this may be addressed by culturally-tailored lifestyle interventions to help African American (AA) endometrial cancer survivors lose weight or maintain a healthy weight. OBJECTIVE: The overall purpose of this pilot study is to develop and evaluate a culturally-tailored lifestyle intervention to help AA uterine cancer survivors reduce their risk of cancer recurrence and improve their quality of life through healthy eating, physical activity, and weight management...
December 2017: Contemporary Clinical Trials Communications
H Angier, N Huguet, M Marino, M Mori, K Winters-Stone, J Shannon, L Raynor, H Holderness, J E DeVoe
Background: Cancer is the second most common cause of mortality in the United States. Cancer screening and prevention services have contributed to improved overall cancer survival rates in the past 40 years. Vulnerable populations (i.e., uninsured, low-income, and racial/ethnic minorities) are disproportionately affected by cancer, receive significantly fewer cancer prevention services, poorer healthcare, and subsequently lower survival rates than insured, white, non-Hispanic populations...
September 2017: Contemporary Clinical Trials Communications
Juan Espinoza, Alexander Chen, Jazminne Orozco, Alexis Deavenport-Saman, Larry Yin
Background: Childhood obesity continues to be a substantial problem despite major public health efforts, and disproportionately impacts children from low-income families. Digital health tools and consumer technology offer promising opportunities for interventions, but few studies have evaluated how they might be incorporated into existing interventions or used to create new types of interventions. It remains unclear which approaches would be most beneficial for underserved pediatric populations...
September 2017: Contemporary Clinical Trials Communications
Melanie Abrahamson, Elizabeth Hooker, Nadim J Ajami, Joseph F Petrosino, Eric S Orwoll
The relationship of the gastrointestinal microbiome to health and disease is of major research interest, including the effects of the gut microbiota on age related conditions. Here we report on the outcome of a project to collect stool samples on a large number of community dwelling elderly men using the OMNIgene-GUT stool/feces collection kit (OMR-200, DNA Genotek, Ottawa, Canada). Among 1,328 men who were eligible for stool collection, 982 (74%) agreed to participate and 951 submitted samples. The collection process was reported to be acceptable, almost all samples obtained were adequate, the process of sample handling by mail was uniformly successful...
September 2017: Contemporary Clinical Trials Communications
Mary A Garza, Sandra Crouse Quinn, Yan Li, Luciana Assini-Meytin, Erica T Casper, Craig S Fryer, James Butler, Natasha A Brown, Kevin H Kim, Stephen B Thomas
INRODUCTION: The purpose of this study was to explore factors associated with willingness of African Americans and Latinos to participate in biomedical and public health research and to delineate factors that influences the decision to become a human subject. METHODS: We present results from a 2010 random digit-dial telephone survey of 2,455 African American (N= 1,191) and Latino (N= 1,264) adults. We used standard measures to assess knowledge of research, terminology, informed consent procedures, previous participation in research, health care experiences, social support, risk perception, religiousness, and trust...
September 2017: Contemporary Clinical Trials Communications
Terry Bush, Jennifer Lovejoy, Harold Javitz, Stacey Mahuna, Alula Jimenez Torres, Ken Wassum, Brooke Magnusson, Cody Benedict, Bonnie Spring
Background: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. Methods: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management...
September 2017: Contemporary Clinical Trials Communications
Chunyan Cai, Mohammad H Rahbar, Md Monir Hossain, Ying Yuan, Nicole R Gonzales
Traditional dose-finding designs do not require assignment of patients to a control group. Motivated by SHRINC (Safety of Pioglitazone for hematoma resolution in intracerebral hemorrhage), we developed a placebo-controlled dose-finding study to identify the maximum tolerated dose for pioglitazone in stroke patients with spontaneous intracerebral hemorrhage. We designed an extension of the continuous reassessment method that allowed to incorporate information from the control group (i.e., the standard of care), and utilized it to determine the maximum tolerated dose in the SHRINC trial...
September 2017: Contemporary Clinical Trials Communications
Sin-Ho Jung
With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial...
September 2017: Contemporary Clinical Trials Communications
Tsung-Ta Hsieh, Meng Lee, Wen-Yi Huang, Sung-Chun Tang, Sheng-Feng Sung, Kuo-Husan Chang, Jiann-Der Lee, Tsong-Hai Lee, Yung-Sung Huang, Jiann-Shing Jeng, Chang-Min Chung, Yi-Ling Wu, Bruce Ovbiagele
BACKGROUND: Enhancing detection of undiagnosed atrial fibrillation (AF) in hospitalized patients with a recent ischemic stroke is important because of the treatment implications; especially since presence of paroxysmal AF may not be picked up in a single 12-lead electrocardiogram (ECG) test. While several trials have shown improved detection of AF with prolonged ECG monitoring, this strategy is associated with relatively high cost, labor intensity, and patient inconvenience, thereby making it challenging to routinely implement in all hospitals...
June 2017: Contemporary Clinical Trials Communications
Donna M Evon, Carol E Golin, Rachel Ruffin, Michael W Fried
Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design...
June 2017: Contemporary Clinical Trials Communications
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