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Contemporary Clinical Trials Communications

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https://www.readbyqxmd.com/read/28798964/design-of-phase-ii-non-inferiority-trials
#1
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
https://www.readbyqxmd.com/read/28752133/comparison-of-recruitment-and-retention-among-demographic-subgroups-in-a-large-diverse-population-study-of-diet
#2
Gwen L Alexander, Sujata Dixit-Joshi, Lawrence H Kushi, Laura A Coleman, Maria E Sundaram, Heather A Clancy, Michelle Groesbeck, Nancy A Potischman, Sharon I Kirkpatrick, Thea P Zimmerman, Stephanie M George, Amy F Subar, Frances E Thompson
OBJECTIVE: We examined the feasibility of conducting a longitudinal study of diet among diverse populations by comparing rates of response throughout recruitment and retention phases by demographic and other characteristics. METHODS: Using quota sampling, participants were recruited from 3 geographically and demographically diverse integrated health systems in the United States. Overall, 12,860 adults, ages 20-70, were invited to participate via mail. Participation first required accessing the study's website and later meeting eligibility criteria via telephone interview...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28736754/age-related-macular-degeneration-in-a-randomized-controlled-trial-of-low-dose-aspirin-rationale-and-study-design-of-the-aspree-amd-study
#3
Liubov Robman, Robyn Guymer, Robyn Woods, Stephanie Ward, Rory Wolfe, James Phung, Lauren Hodgson, Galina Makeyeva, Khin Zaw Aung, Tom Gilbert, Jessica Lockery, Y-Anh Le-Pham, Suzanne Orchard, Elsdon Storey, Walter Abhayaratna, Daniel Reid, Michael E Ernst, Mark Nelson, Christopher Reid, John McNeil
PURPOSE: Although aspirin therapy is used widely in older adults for prevention of cardiovascular disease, its impact on the incidence, progression and severity of age-related macular degeneration (AMD) is uncertain. The effect of low-dose aspirin on the course of AMD will be evaluated in this clinical trial. DESIGN: A sub-study of the 'ASPirin in Reducing Events in the Elderly' (ASPREE) trial, ASPREE-AMD is a 5-year follow-up double-blind, placebo-controlled, randomized trial of the effect of 100 mg daily aspirin on the course of AMD in 5000 subjects aged 70 years or older, with normal cognitive function and without cardiovascular disease at baseline...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28670629/statistical-analysis-plan-for-stage-1-embarc-establishing-moderators-and-biosignatures-of-antidepressant-response-for-clinical-care-study
#4
Eva Petkova, R Todd Ogden, Thaddeus Tarpey, Adam Ciarleglio, Bei Jiang, Zhe Su, Thomas Carmody, Philip Adams, Helena C Kraemer, Bruce D Grannemann, Maria A Oquendo, Ramin Parsey, Myrna Weissman, Patrick J McGrath, Maurizio Fava, Madhukar H Trivedi
Antidepressant medications are commonly used to treat depression, but only about 30% of patients reach remission with any single first-step antidepressant. If the first-step treatment fails, response and remission rates at subsequent steps are even more limited. The literature on biomarkers for treatment response is largely based on secondary analyses of studies designed to answer primary questions of efficacy, rather than on a planned systematic evaluation of biomarkers for treatment decision. The lack of evidence-based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially designed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28649668/metabolic-costs-of-daily-activity-in-older-adults-chores-xl-study-design-and-methods
#5
Duane B Corbett, Amal A Wanigatunga, Vincenzo Valiani, Eileen M Handberg, Thomas W Buford, Babette Brumback, Ramon Casanova, Christopher M Janelle, Todd M Manini
BACKGROUND: For over 20 years, normative data has guided the prescription of physical activity. This data has since been applied to research and used to plan interventions. While this data seemingly provides accurate estimates of the metabolic cost of daily activities in young adults, the accuracy of use among older adults is less clear. As such, a thorough evaluation of the metabolic cost of daily activities in community dwelling adults across the lifespan is needed. METHODS: The Metabolic Costs of Daily Activity in Older Adults Study is a cross-sectional study designed to compare the metabolic cost of daily activities in 250 community dwelling adults across the lifespan...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28626811/the-enrich-study-to-evaluate-the-effectiveness-of-a-combination-intervention-package-to-improve-isoniazid-preventive-therapy-initiation-adherence-and-completion-among-people-living-with-hiv-in-ethiopia-rationale-and-design-of-a-mixed-methods-cluster-randomized
#6
Andrea A Howard, Yael Hirsch-Moverman, Suzue Saito, Tsigereda Gadisa, Amrita Daftary, Zenebe Melaku
BACKGROUND: Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. OBJECTIVE: The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. DESIGN: Ten health centers were randomized to receive the CIP or standard of care...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28508087/the-vitamin-d-for-enhancing-the-immune-system-in-cystic-fibrosis-disc-trial-rationale-and-design-of-a-multi-center-double-blind-placebo-controlled-trial-of-high-dose-bolus-administration-of-vitamin-d3-during-acute-pulmonary-exacerbation-of-cystic-fibrosis
#7
Vin Tangpricha, Ellen M Smith, Jose Binongo, Suzanne E Judd, Thomas R Ziegler, Seth Walker, Rabindra Tirouvanziam, Susu M Zughaier, Moon Jeong Lee, Supavit Chesdachai, Wendy A Hermes, James F Chmiel, Amit Gaggar, Ruth E Grossmann, Patricia M Joseph, Jessica A Alvarez
Vitamin D deficiency is highly prevalent in children and adults with cystic fibrosis (CF). Recent studies have found an association between vitamin D status and risk of pulmonary exacerbations in children and adults with CF. The ongoing Vitamin D for enhancing the Immune System in Cystic fibrosis (DISC) study is a multi-center, double-blind, randomized, placebo-controlled trial that will test the hypothesis of whether high dose vitamin D given as a single oral bolus of 250,000 IU to adults with CF during a pulmonary exacerbation followed by a maintenance dose of vitamin D will improve time to next pulmonary exacerbation and re-hospitalization, improve survival and lung function compared to placebo and reduce the rates of pulmonary exacerbation,...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28685168/recruitment-challenges-and-enrollment-observations-from-a-community-based-intervention-mothers-in-motion-for-low-income-overweight-and-obese-women
#8
Mei-Wei Chang, Susan Nitzke, Roger Brown, M Jean Brancheau Egan, Christopher M Bendekgey, Diana Buist
BACKGROUND: Mothers In Motion (MIM), a randomized controlled trial, aimed to help young, low-income overweight and obese mothers prevent weight gain by promoting stress management, healthy eating, and physical activity. This paper describes MIM recruitment challenges and reports demographic characteristics affecting enrollment. METHODS: Participants who were African American or Non-Hispanic White were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Michigan...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28424796/external-data-required-timely-response-by-the-trial-steering-data-monitoring-committee-for-the-naloxone-investigation-n-alive-pilot-trial
#9
Sheila M Bird, John Strang, Deborah Ashby, John Podmore, J Roy Robertson, Sarah Welch, Angela M Meade, Mahesh K B Parmar
The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC) on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR) from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28424795/an-open-label-cluster-randomised-trial-to-evaluate-the-effectiveness-of-a-counselling-intervention-on-linkage-to-care-among-hiv-infected-patients-in-uganda-study-design
#10
Eugene Ruzagira, Kathy Baisley, Anatoli Kamali, Heiner Grosskurth
INTRODUCTION: Home-based HIV counselling & testing (HBHCT) is highly acceptable and has the potential to increase HIV testing uptake in sub-Saharan Africa. However, data are lacking on strategies that can effectively link HIV-positive individuals identified through HBHCT to care. This trial was designed to assess the effectiveness of two brief home-based counselling sessions on linkage to care, provided subsequent to referral for care among HIV-positive patients identified through HBHCT in a rural community in Masaka district, Uganda...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28424794/study-design-and-baseline-results-of-an-open-label-cluster-randomized-community-intervention-trial-to-assess-the-effectiveness-of-a-modified-mass-deworming-program-in-reducing-hookworm-infection-in-a-tribal-population-in-southern-india
#11
Rajiv Sarkar, Anuradha Rose, Venkata R Mohan, Sitara S R Ajjampur, Vasanthakumar Veluswamy, Rajan Srinivasan, Jayaprakash Muliyil, Vedantam Rajshekhar, Kuryan George, Vinohar Balraj, Nicholas C Grassly, Roy M Anderson, Simon J Brooker, Gagandeep Kang
INTRODUCTION: Hookworm infection is a leading cause of iron deficiency anemia and malnutrition in resource-poor settings. Periodic mass deworming with anthelminthic drugs remains the cornerstone of hookworm control efforts worldwide. Reinfection following treatment occurs, reflecting the human host's inability to acquire immunity following exposure to an untreated reservoir of infection. This cluster randomized trial will evaluate the effectiveness of a modified, population-based, mass deworming strategy in reducing hookworm infection in an endemic southern Indian population...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28378019/a-successful-approach-to-minimizing-attrition-in-racial-ethnic-minority-low-income-populations
#12
Glenn Flores, Alberto Portillo, Hua Lin, Candy Walker, Marco Fierro, Monica Henry, Kenneth Massey
BACKGROUND: Recruiting and retaining minority participants in clinical trials continue to be major challenges. Although multiple studies document lower minority trial enrollment, much less is known about effective minority retention strategies. Our objectives were to evaluate an innovative approach to high RCT retention of minority children, and identify child/caregiver characteristics predicting attrition. METHODS: The Kids' HELP trial examined the effects of Parent Mentors on insuring uninsured minority children...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28217765/personalized-medicine-enrichment-design-for-dha-supplementation-clinical-trial
#13
Yang Lei, Matthew S Mayo, Susan E Carlson, Byron J Gajewski
Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28770256/focus-on-you-cancer-clinical-trials-perspectives
#14
Brandi N Robinson, Antoinette F Newman, Sherrie F Wallington, Sandra M Swain
BACKGROUND: Clinical trials test new ways to prevent, detect, diagnose, or treat diseases. Researchers have found that minority patients are willing to participate in clinical trials, yet these patients have barriers which hinder their access to trials. METHODS: To explore African American women's participation in breast cancer clinical trials, eight focus groups were conducted with breast cancer patients, family members/care givers, religious leaders, and healthcare providers to gather information on the perspectives and opinions on the topic...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28191546/customized-care-an-intervention-to-improve-communication-and-health-outcomes-in-multimorbidity
#15
Marsha N Wittink, Sule Yilmaz, Patrick Walsh, Ben Chapman, Paul Duberstein
INTRODUCTION: Many primary care patients with multimorbidity (two or more chronic conditions) and depression or anxiety have day-to-day challenges that affect health outcomes, such as having financial or housing concerns, or dealing with social or emotional stressors. Yet, primary care providers (PCPs) are often unaware of patients' daily challenges coping with chronic disease. We developed Customized Care, an intervention, to address the barriers to effective communication about patient's day-to-day challenges...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28184381/a-multicenter-longitudinal-interventional-double-blind-randomized-clinical-trial-in-hematopoietic-cell-transplant-recipients-residing-in-remote-areas-lessons-learned-from-the-late-cytomegalovirus-prevention-trial
#16
Louise E Kimball, Terry Stevens-Ayers, Margaret L Green, Hu Xie, Mary E D Flowers, Keith R Jerome, Renee LeBlanc, Christi Dahlgren, W Garrett Nichols, Roy F Chemaly, G Papanicolaou, Michael Boeckh
PURPOSE: The logistics of conducting double-blinded phase III clinical trials with participants residing in remote locations are complex. Here we describe the implementation of an interventional trial for the prevention of late cytomegalovirus (CMV) disease in hematopoietic cell transplantation (HCT) subjects in a long-term follow-up environment. METHODS: A total of 184 subjects at risk for late CMV disease surviving 80 days following allogeneic HCT were randomized to receive six months of valganciclovir or placebo...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28042619/beating-the-odds-successful-establishment-of-a-phase-ii-iii-clinical-research-trial-in-resource-poor-liberia-during-the-largest-ever-ebola-outbreak
#17
J Doe-Anderson, B Baseler, P Driscoll, M Johnson, J Lysander, L McNay, W S Njoh, M Smolskis, L Wehrlen, J Zuckerman
It has been argued that a country such as Liberia, not fully recovered from the devastation of decades of civil unrest, lacked the appropriate ethical and regulatory framework, basic human and health care services, and infrastructure to carry out clinical trials according to international standards of quality during a public health emergency. However, as Liberia, Sierra Leone, and Guinea were being ravaged by the largest and most devastating Ebola Virus Disease (EVD) outbreak ever recorded, the topic of conducting clinical trials of experimental vaccine and treatment candidates in these resource-poor countries generated the keen interest and concern of scientists, researchers, physicians, bioethicists, philanthropists, and even politicians...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27900372/application-of-the-marginal-structural-model-to-account-for-suboptimal-adherence-in-a-randomized-controlled-trial
#18
James Rochon, Manjushri Bhapkar, Carl F Pieper, William E Kraus
BACKGROUND: There is considerable interest in adjusting for suboptimal adherence in randomized controlled trials. A per-protocol analysis, for example removes individuals who fail to achieve a minimal level of adherence. One can also reassign non-adherers to the control group, censor them at the point of non-adherence, or cross them over to the control. However, there are biases inherent in each of these methods. Here, we describe an application of causal modeling to address this issue...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27766318/intra-cluster-correlation-estimates-for-hiv-related-outcomes-from-care-and-treatment-clinics-in-dar-es-salaam-tanzania
#19
Dale Barnhart, Ellen Hertzmark, Enju Liu, Ester Mungure, Aisa N Muya, David Sando, Guerino Chalamilla, Nzovu Ulenga, Till Bärnighausen, Wafaie Fawzi, Donna Spiegelman
INTRODUCTION: Researchers planning cluster-randomized controlled trials (cRCTs) require estimates of the intra-cluster correlation coefficient (ICC) from previous studies for sample size calculations. This paper fills a persistent gap in the literature by providing estimates of ICCs for many key HIV-related clinical outcomes. METHODS: Data from HIV-positive patients from 47 HIV care and treatment clinics in Dar es Salaam, Tanzania were used to calculate ICCs by site of enrollment or site of ART initiation for various clinical outcomes using cross-sectional and longitudinal data...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27754492/school-based-mindfulness-intervention-for-stress-reduction-in-adolescents-design-and-methodology-of-an-open-label-parallel-group-randomized-controlled-trial
#20
Jeanette M Johnstone, Chelsea Roake, Ifrah Sheikh, Ashlie Mole, Joel T Nigg, Barry Oken
Adolescents are in a high-risk period developmentally, in terms of susceptibility to stress. A mindfulness intervention represents a potentially useful strategy for developing cognitive and emotion regulation skills associated with successful stress coping. Mindfulness strategies have been used successfully for emotional coping in adults, but are not as well studied in youth. This article details a novel proposal for the design of an 8-week randomized study to evaluate a high school-based mindfulness curriculum delivered as part of a two semester health class...
December 15, 2016: Contemporary Clinical Trials Communications
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