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Contemporary Clinical Trials Communications

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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
#1
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
#2
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
#3
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
#4
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
#5
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/28191546/customized-care-an-intervention-to-improve-communication-and-health-outcomes-in-multimorbidity
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/27570845/mexican-american-perspectives-on-participation-in-clinical-trials-a-qualitative-study
#12
Mariana Arevalo, Natalia I Heredia, Sarah Krasny, Maria L Rangel, Leticia A Gatus, Lorna H McNeill, Maria E Fernandez
Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128) stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1) knowledge and understanding of clinical trials, 2) fears and concerns about participating, 3) perceived benefits of participating, and 4) incentives to participate...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27489888/methods-to-reduce-medication-errors-in-a-clinical-trial-of-an-investigational-parenteral-medication
#13
Gillian L Fell, Alison A O'Loughlin, Prathima Nandivada, Alexis K Potemkin, Paul D Mitchell, Judith Mahoney, Kathleen M Gura, Mark Puder
There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8-24 hours, and variable treatment durations for each patient. We report study design modifications made in 2007-2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27458608/exploring-willingness-of-elder-chinese-in-houston-to-participate-in-clinical-research
#14
Logan R Thornton, Rossybelle P Amorrortu, Daniel W Smith, Arch G Mainous, Sally W Vernon, Barbara C Tilley
BACKGROUND AND OBJECTIVES: Inadequate minority participation in clinical research can threaten the applicability and strength of scientific findings. Previous research suggests that trial participation rates are lowest among Asian Americans, compared to other groups. This study explored barriers to clinical research participation among elder Chinese living in Houston, Texas. Additionally we administered the Trust in Medical Researchers Scale (TIMRS), used previously in researching trust in medical researchers as related to research participation...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27453960/a-multi-modal-intervention-for-activating-patients-at-risk-for-osteoporosis-apropos-rationale-design-and-uptake-of-online-study-intervention-material
#15
Maria I Danila, Ryan C Outman, Elizabeth J Rahn, Amy S Mudano, Tammi F Thomas, David T Redden, Jeroan J Allison, Fred A Anderson, Julia P Anderson, Peter M Cram, Jeffrey R Curtis, Liana Fraenkel, Susan L Greenspan, Andrea Z LaCroix, Sumit R Majumdar, Michael J Miller, Jeri W Nieves, Monika M Safford, Stuart L Silverman, Ethel S Siris, Daniel H Solomon, Amy H Warriner, Nelson B Watts, Robert A Yood, Kenneth G Saag
OBJECTIVE: To develop an innovative and effective educational intervention to inform patients about the need for osteoporosis treatment and to determine factors associated with its online uptake. METHODS: Postmenopausal women with a prior fracture and not currently using osteoporosis therapy were eligible to be included in the Activating Patients at Risk for OsteoPOroSis (APROPOS). Four nominal groups with a total of 18 racially/ethnically diverse women identified osteoporosis treatment barriers...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27981259/assessment-of-adherence-to-visual-correction-and-occlusion-therapy-in-the-infant-aphakia-treatment-study
#16
Carolyn Drews-Botsch, George Cotsonis, Marianne Celano, Scott R Lambert
Occlusion therapy throughout early childhood is believed to be efficacious in treating deprivation amblyopia but has not been rigorously assessed in clinical trials. Further, tools to assess adherence to such therapy over an extended period of time are lacking. Using data from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for unilateral congenital cataract, we examined the use of quarterly 48-hour recall interviews and annual 7-day prospective diaries to assess reported hours of patching in 114 children throughout the first 5 years of life...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822570/falls-as-adverse-events-in-psychosocial-treatment-of-depression-findings-from-a-clinical-trial-in-nursing-homes
#17
Suzanne Meeks, Brian M Ludwin, Stephen W Looney
Falls pose a significant health risk for nursing home residents and are associated with depression and medical treatments for depression. Data on falls as an adverse event to psychosocial treatments are lacking. We examined risk of falls as an adverse event in a clinical trial of a behavioral treatment for depression. Participants were 82 depressed nursing home residents. Adverse events were recorded at each research contact. We used the rate ratio based on the respective incidence densities in the treatment and control groups to measure association between fall rate and treatment...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822569/trends-in-research-with-u-s-military-service-member-participants-a-population-specific-clinicaltrials-gov-review
#18
Wendy A Cook, Ardith Z Doorenbos, Elizabeth J Bridges
BACKGROUND: ClinicalTrials.gov reviews have evaluated research trends for specific conditions and age groups but not for specific populations of research participants. No ClinicalTrials.gov reviews have evaluated research with military service member participants. PURPOSE: Study objectives were (a) to use ClinicalTrials.gov to identify trends in biomedical research from 2005 to 2014 in which U.S. military service members actively participated as research participants and (b) to describe a search strategy for adaptation in future ClinicalTrials...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822568/random-guess-and-wishful-thinking-are-the-best-blinding-scenarios
#19
Heejung Bang
Blinding is a methodologic safeguard of treatment evaluation, yet severely understudied empirically. Mathieu et al.'s theoretical analysis (2014) provided an important message that blinding cannot eliminate potential for bias associated with belief about allocation in randomized controlled trial; just like the intent-to-treat principle does not guarantee unbiased estimation under noncompliance, the blinded randomized trial as a golden standard may produce bias. They showed possible biases but did not assess how large the bias could be in different scenarios...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822567/lifestyle-modification-intervention-for-overweight-and-obese-hispanic-pregnant-women-development-implementation-lessons-learned-and-future-applications
#20
Roxana Torres, Sandra Soltero, Maria Angelica Trak, Carolyn M Tucker, Keimari Mendez, Maribel Campos, Walter Willett, Marytere Melendez, Mathew W Gillman, Paul W Franks, Kaumudi Joshipura, Jeremy Pomeroy, Cristina Palacios
OBJECTIVES: To describe the development, implementation and lessons learned of lifestyle intervention to promote appropriate gestational weight gain among Hispanic pregnant women. DESIGN: The intervention was informed by an empowerment oriented theoretical framework, and targeted women in the Pregnancy and Early Life Improvement Study. METHODS: The nutrition component consisted of recommendations for total calories, food quantity and improving carbohydrate and fat quality...
August 15, 2016: Contemporary Clinical Trials Communications
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