1,862 results match your criteria Contemporary clinical trials[Journal]


Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial.

Contemp Clin Trials 2019 Feb 16. Epub 2019 Feb 16.

Division of Neurology, University of Alberta, 11350-83 Avenue, 7-112 Clinical Sciences Building, Edmonton, AB T6G 2G3, Canada. Electronic address:

Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better meet these needs. While PC has been shown to improve care and quality of life (QOL) for people with cancer and heart failure, few studies have evaluated the role of PC for people with PDRD. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.005DOI Listing
February 2019
2 Reads

Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

Contemp Clin Trials 2019 Feb 14. Epub 2019 Feb 14.

NorthShore University HealthSystem, University of Illinois at Chicago, United States.

Objective: To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.

Methods: Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.006DOI Listing
February 2019
1 Read

Arriba por la vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas.

Contemp Clin Trials 2019 Feb 13. Epub 2019 Feb 13.

University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States.

Background: Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidelines. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.004DOI Listing
February 2019
1 Read

A randomized trial of a multi-level intervention to increase water access and appeal in community recreation centers.

Contemp Clin Trials 2019 Feb 13. Epub 2019 Feb 13.

School of Medicine, Stanford University, Stanford, CA, USA; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, CA, USA.

Introduction: Improving children's tap water intake and reducing sugar-sweetened beverage (SSB) consumption is beneficial for health and health equity, particularly in low-income communities and communities of color. Existing community level interventions to improve the intake of tap water have predominantly occurred in schools and have focused on promoting water consumption in cafeterias during lunch or snack periods.

Methods: The "Hydrate Philly" intervention was developed to target multiple environmental and social factors to improve tap water consumption in community recreation centers in low-income communities: replacing old and unappealing water fountains with appealing water-bottle-filling "hydration stations", conducting water safety testing and publicizing results, disseminating reusable water bottles, promoting tap water, and discouraging SSB consumption. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.003DOI Listing
February 2019

Multi-pronged intervention to increase secondary student participation in school lunch: Design and rationale.

Contemp Clin Trials 2019 Feb 13;78:133-139. Epub 2019 Feb 13.

University of California, Berkeley, United States. Electronic address:

Background: In the United States, the National School Lunch Program (NSLP) is the healthiest lunch option for students, yet participation is suboptimal and fruit and vegetable waste remains high. Improving school meal convenience, engaging teachers in the school-lunch program, and enhancing the cafeteria environment are promising strategies to improve participation and dietary intake, yet little evidence is available on their impact.

Methods/design: The Multi-Pronged Intervention to Increase Secondary Student Participation in School Lunch (MPI) is a 3-year quasi-experimental study in a large urban school district in California. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.013DOI Listing
February 2019

Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan.

Contemp Clin Trials 2019 Feb 7;78:126-132. Epub 2019 Feb 7.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University Milan, Italy. Electronic address:

Objective: Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NIV for mild-moderate ARF in non-ICU wards can prevent development of severe ARF.

Design: Pragmatic, parallel group, randomized, controlled, multicenter trial. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.001DOI Listing
February 2019
1 Read

Study protocol and baseline sample characteristics: From clinic to community: Using peer support as a transition model for improving long-term diabetes-related health outcomes.

Contemp Clin Trials 2019 Feb 7. Epub 2019 Feb 7.

Division of Endocrinology, Department of Medicine, The University of British Columbia, Canada. Electronic address:

Background: The objective of this randomized controlled trial is to examine the effects of a 12-month telephone-based peer-led diabetes self-management support (DSMS) intervention on long-term diabetes-related health outcomes.

Methods: In total, 197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics). They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care. Read More

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http://dx.doi.org/10.1016/j.cct.2019.02.002DOI Listing
February 2019

Intervention Comparative Effectiveness for Adult Cognitive Training (ICE-ACT) Trial: Rationale, design, and baseline characteristics.

Contemp Clin Trials 2019 Jan 31;78:76-87. Epub 2019 Jan 31.

Florida State University, Department of Psychology, Tallahassee, FL, United States.

Age-related perceptual and cognitive declines are associated with difficulties performing everyday tasks required to remain independent. Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence. This project compares the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.014DOI Listing
January 2019
1 Read
1.986 Impact Factor

A brief intervention to increase uptake and adherence of an online program for depression and anxiety: Protocol for the Enhancing Engagement with Psychosocial Interventions (EEPI) Randomized Controlled Trial.

Contemp Clin Trials 2019 Jan 31;78:107-115. Epub 2019 Jan 31.

Centre for Mental Health Research, Research School of Population Health, The Australian National University, Australia.

Background: There is substantial evidence that psychosocial programs delivered online can be effective in treating and preventing mental health problems. However, use of evidence-based programs in the community is currently suboptimal, and there is a lack of evidence around how to increase engagement with existing evidence-based programs. Novel approaches to increasing the acceptability of online programs such as the use of brief engagement-facilitation interventions (EFI) require evaluation. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.015DOI Listing
January 2019

The Healthy Pregnancies Project: Study protocol and baseline characteristics for a cluster-randomized controlled trial of a community intervention to reduce tobacco use among Alaska Native pregnant women.

Contemp Clin Trials 2019 Jan 28;78:116-125. Epub 2019 Jan 28.

Native American Cancer Initiatives, Inc., 3022 South Nova Road, Pine, CO 80470, USA. Electronic address:

Background: Tobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.012DOI Listing
January 2019

Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

Contemp Clin Trials 2019 Jan 21;78:88-100. Epub 2019 Jan 21.

School of Nursing, University of Wisconsin, Signe Skott Cooper Hall, 701 Highland Avenue, Madison, WI 53705, USA. Electronic address:

Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.010DOI Listing
January 2019
1 Read

Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

Contemp Clin Trials 2019 Jan 18. Epub 2019 Jan 18.

Washington University School of Medicine, Department of Medicine, Division of Geriatrics and Nutritional Science, 660 S. Euclid, Campus Box 8083, St. Louis, MO 63110, United States.

Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.011DOI Listing
January 2019
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Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods.

Contemp Clin Trials 2019 Jan 16;78:27-33. Epub 2019 Jan 16.

Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States. Electronic address:

Asthma causes enormous suffering and cost for children in the US and around the world [1-3]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more difficult due to increased symptoms. Proton pump inhibitor (PPI) drugs are effective at improving to GERD symptoms, however they have demonstrated only modest and variable effects on asthma control in the setting of co-morbid GERD. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183065
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http://dx.doi.org/10.1016/j.cct.2019.01.009DOI Listing
January 2019
3 Reads

An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial.

Contemp Clin Trials 2019 Jan 14;78:11-19. Epub 2019 Jan 14.

Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States.

Background: The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.008DOI Listing
January 2019
5 Reads

Preliminary efficacy and feasibility of referral to exercise specialists, psychologists and provision of a technology-based behavior change support package to promote physical activity in school teachers 'at risk' of, or diagnosed with, type 2 diabetes: The 'SMART Health' Pilot Study Protocol.

Contemp Clin Trials 2019 Jan 11;78:53-62. Epub 2019 Jan 11.

University of Newcastle, Australia, Priority Research Centre for Physical Activity and Nutrition, Level 3 Advanced Technology Centre (ATC316), Callaghan, NSW 2308, Australia. Electronic address:

Introduction: Type 2 diabetes mellitus (T2DM) is a global public health concern. Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM. The aim of this pilot trial is to determine the preliminary efficacy and confirm feasibility of referral to exercise physiologists, psychologists, and provision of a technology-based behavior change support package to promote aerobic PA and RT in school teachers 'at risk' of or diagnosed with T2DM. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.007DOI Listing
January 2019
8 Reads

Minimally Invasive coronary surgery compared to STernotomy coronary artery bypass grafting: The MIST trial.

Contemp Clin Trials 2019 Jan 8;78:140-145. Epub 2019 Jan 8.

Division of cardiac surgery, University of Ottawa Heart Institute, Ottawa, Canada. Electronic address:

Rationale: Minimally invasive cardiac surgery has emerged as a safe alternative to standard cardiac surgery. Minimally invasive coronary surgery (MICS CABG) was developed to allow adequate exposure and complete revascularization in CABG from a small thoracotomy incision without cardiopulmonary bypass. Multiple studies have reported significant shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183037
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http://dx.doi.org/10.1016/j.cct.2019.01.006DOI Listing
January 2019
3 Reads

Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring.

Contemp Clin Trials 2019 Jan 8. Epub 2019 Jan 8.

University of Washington, Department of Family Medicine, United States.

Background: The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study comparing the accuracy and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.003DOI Listing
January 2019
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Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: A systematic review.

Contemp Clin Trials 2019 Jan 8;78:1-10. Epub 2019 Jan 8.

Background: People from ethnic minorities are reported to have higher rates of physical illness (diabetes and ischemic heart disease) and mental disorders. Disparities relate not just to diagnosis, but also to care pathways and treatment outcomes. Despite this, they are underrepresented in clinical research. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.004DOI Listing
January 2019
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Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

Contemp Clin Trials 2019 Jan 7;78:34-45. Epub 2019 Jan 7.

Department of Nutrition, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States; Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States. Electronic address:

Background: Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. Read More

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http://dx.doi.org/10.1016/j.cct.2019.01.002DOI Listing
January 2019
10 Reads

iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children.

Contemp Clin Trials 2019 Jan 7;78:20-26. Epub 2019 Jan 7.

Department of Counseling, School, and Educational Psychology, Graduate School of Education, University at Buffalo - SUNY, 420 Baldy Hall, Buffalo, NY 14260, United States.

Children in rural areas are disproportionately affected by pediatric obesity. Poor access to healthcare providers, lack of nutrition education, lower socioeconomic status, and fewer opportunities to be physically active are all unique barriers that contribute to this growing health concern. There are very few pediatric obesity interventions that have been developed that target this unique population. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183053
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http://dx.doi.org/10.1016/j.cct.2019.01.001DOI Listing
January 2019
6 Reads

STRONG-D: Strength training regimen for normal weight diabetics: Rationale and design.

Contemp Clin Trials 2019 Jan 6;78:101-106. Epub 2019 Jan 6.

Department of Primary Care and Population Health, Stanford University School of Medicine, Palo Alto, CA, United States.

Background: Currently, there is a lack of data on effective lifestyle recommendations for normal-weight diabetics (NWD), who can represent up to 1 in 5 individuals with Type II Diabetes Mellitus (T2DM). NWD is especially prevalent in Asian populations and the elderly. Specific exercise treatment recommendations are needed for patients with normal-weight diabetes (NWD), as those in this category face higher mortality rates than overweight and obese diabetics. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183043
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http://dx.doi.org/10.1016/j.cct.2019.01.005DOI Listing
January 2019
3 Reads
1.986 Impact Factor

Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care.

Contemp Clin Trials 2018 Dec 26;78:63-75. Epub 2018 Dec 26.

The Department of General Practice, Melbourne Medical School, University of Melbourne.

Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.014DOI Listing
December 2018
1 Read

Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era.

Contemp Clin Trials 2019 Feb 27;77:98-103. Epub 2018 Dec 27.

University of California San Francisco, San Francisco, CA.

Precision medicine is expected to impact the care of people with asthma, given its high disease prevalence, heterogeneity of pathophysiologic mechanisms, and consequent clinical phenotypes. A novel phenotype-stratified clinical trial conducted by the NHLBI AsthmaNet Consortium, titled Steroids in Eosinophil Negative Asthma (SIENA), was a randomized, multicenter, clinical trial that prospectively stratified individuals according to their baseline level of sputum inflammation during a screening period. Two phenotypic strata were assigned based on an a priori defined extent of sputum eosinophilia (Eos Low versus Eos High). Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.012DOI Listing
February 2019
4 Reads

Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial.

Contemp Clin Trials 2019 Feb 26;77:70-75. Epub 2018 Dec 26.

School of Nursing, The University of Hong Kong, Hong Kong. Electronic address:

Background: Novel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.013DOI Listing
February 2019
2 Reads

In-home obesity prevention in low-income infants through maternal and social transmission.

Contemp Clin Trials 2019 Feb 19;77:61-69. Epub 2018 Dec 19.

Research Center for Health Equity, Cedars-Sinai Medical Center, 116 N Robertson Blvd PACT Bldg 909, Los Angeles, CA 90048, United States. Electronic address:

Background: Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families.

Methods: This two-arm, parallel, randomized controlled trial (RCT) tests whether delivering obesity prevention, as part of an ongoing home visitation program (HVP), is an effective approach for primary (infants) and secondary (mothers) obesity prevention among low-income, underserved families. This RCT further examines the role of maternal and social factors as key mechanisms of transmission of infants' obesity risk, and the real-life costs of delivering obesity prevention as part of HVPs. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.010DOI Listing
February 2019
1 Read

Improving anti-platelet therapy adherence in the Veterans Health Administration: A randomized multi-site hybrid effectiveness-implementation study protocol.

Contemp Clin Trials 2019 Feb 19;77:104-110. Epub 2018 Dec 19.

VHA Eastern Colorado Health Care System, Denver, CO, United States.

Background: P2Y12 inhibitors are critical following percutaneous coronary intervention (PCI) with stent placement; they reduce the risk of stent thrombosis and myocardial infarction. Despite the importance of the therapy, non-adherence is common among Veterans.

Methods And Results: Our main objective is to conduct a multi-site randomized stepped wedge trial to test the effectiveness of a multi-faceted intervention to improve adherence to P2Y12 inhibitors and PCI outcomes as well as formatively evaluate and refine the intervention implementation process. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183040
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http://dx.doi.org/10.1016/j.cct.2018.12.005DOI Listing
February 2019
7 Reads

Enhancing individual placement and support (IPS) - Supported employment: A Type 1 hybrid design randomized controlled trial to evaluate virtual reality job interview training among adults with severe mental illness.

Contemp Clin Trials 2019 Feb 18;77:86-97. Epub 2018 Dec 18.

Thresholds Inc, USA; Chicago Department of Psychiatry, University of Illinois, USA.

Individual Placement and Support (IPS) is the evidence-based model of supported employment that increases employment rates in adults with severe mental illness (SMI). Although IPS is largely successful, over 80% of adults with SMI remain unemployed. An enhancement to high fidelity IPS could be an evidence-based job interview training component. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.008DOI Listing
February 2019
1 Read
1.986 Impact Factor

Rationale and design of Smart Walk: A randomized controlled pilot trial of a smartphone-delivered physical activity and cardiometabolic risk reduction intervention for African American women.

Contemp Clin Trials 2019 Feb 18;77:46-60. Epub 2018 Dec 18.

Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, 500 N 3rd St, Phoenix, AZ 85004, USA. Electronic address:

Background: African American (AA) women perform low levels of physical activity (PA) and are disproportionally burdened by cardiometabolic disease conditions when compared to White women and the U.S. population as a whole. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6344046PMC
February 2019
1 Read

Optimizing pain treatment interventions (OPTI): A pilot randomized controlled trial of collaborative care to improve chronic pain management and opioid safety-Rationale, methods, and lessons learned.

Contemp Clin Trials 2019 Feb 17;77:76-85. Epub 2018 Dec 17.

VA Palo Alto Health Care System, Center for Innovation to Implementation (Ci2i), United States.

Veterans seeking care in VA medical facilities have high rates of chronic pain, which often co-occur with mental health and substance use disorders, including prescription opioid misuse. The overall goal of the Optimizing Pain Treatment Interventions (OPTI) study was to pilot a 12-week Collaborative Care intervention to improve opioid safety, chronic pain disability, and use of non-pharmacological pain management strategies in veterans in VA primary care. Between November 2014 and January 2017, 100 veteran patients with chronic pain and high-risk prescription opioid use (e. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183056
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http://dx.doi.org/10.1016/j.cct.2018.12.006DOI Listing
February 2019
18 Reads

Dissemination of computer-assisted cognitive-behavior therapy for depression in primary care.

Contemp Clin Trials 2018 Dec 17;78:46-52. Epub 2018 Dec 17.

Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, United States.

Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 240 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting in which there have been significant problems in the delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged (low-income) patients - a population that has been largely ignored in previous research in CCBT. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183013
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http://dx.doi.org/10.1016/j.cct.2018.11.001DOI Listing
December 2018
11 Reads

Design and rationale for evaluating salad bars and students' fruit and vegetable consumption: A cluster randomized factorial trial with objective assessments.

Contemp Clin Trials 2019 Feb 18;77:37-45. Epub 2018 Dec 18.

College of Health Solutions, Arizona State University, 425 N. 5th Street, Phoenix, AZ, United States. Electronic address:

Building healthy fruit and vegetable (FV) consumption habits early in life is critical for primary prevention. However, U.S. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.007DOI Listing
February 2019
1 Read

ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol.

Contemp Clin Trials 2019 Feb 17;77:19-26. Epub 2018 Dec 17.

Center for Behavioral Health, Cleveland Clinic, United States; Center for Behavioral Health, Lutheran Hospital, United States; Cleveland Clinic Lerner, College of Medicine of Case Western Reserve University, United States. Electronic address:

Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited availability, stigma, and concerns about cognitive side effects. Ketamine has emerged as the first rapid-acting antidepressant and shows robust short-term efficacy in clinical trials, but there are concerns about its long-term safety and efficacy. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.009DOI Listing
February 2019
1 Read

YMCA exercise intervention to augment smoking cessation treatment in adults with high anxiety sensitivity: Study protocol for a randomized controlled trial.

Contemp Clin Trials 2019 Feb 15;77:1-7. Epub 2018 Dec 15.

Department of Psychology, Institute for Mental Health Research, University of Texas at Austin, Austin, TX, United States.

Extant evidence suggests that exercise can reduce anxiety related vulnerability factors, such as anxiety sensitivity (AS), or fear of bodily sensations related to anxiety, that negatively impact smoking cessation outcomes. Building upon emerging evidence supporting the efficacy of exercise as an aid for smoking cessation in adults with high AS, we are conducting a trial to examine the efficacy and feasibility of this clinical application when implemented in a community setting. Partnering with the YMCA, this study aims to enroll 150 adults in a standard smoking cessation protocol (i. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.001DOI Listing
February 2019
1 Read

Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors.

Contemp Clin Trials 2019 Feb 12;77:27-36. Epub 2018 Dec 12.

Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, 9300 Campus Pointe Drive, MC 7433, La Jolla, CA 92037, USA. Electronic address:

Background: Young breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health, and contraception.

Purpose: Describe the design and participant characteristics of a randomized controlled trial testing the efficacy of the survivorship care plan on reproductive health (SCP-R) intervention on improving hot flashes, fertility-related concerns, sexual health, and contraception in YBCS.

Methods: SCP-R is a web-based intervention with text message support encompassing evidence- based practices on four reproductive health issues. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.002DOI Listing
February 2019
2 Reads

Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study.

Contemp Clin Trials 2019 Jan 13;76:112-119. Epub 2018 Dec 13.

Department of Rehabilitation Medicine, Box 356490, University of Washington, Seattle, Washington 98195-6490, USA; VA Puget Sound Healthcare System, 1660 S. Columbian Way, RCS-117, Seattle, WA 98108, USA. Electronic address:

Background And Objectives: Chronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI.

Methods: Veterans with a history of TBI and chronic pain of at least six months duration (N = 160) will be randomized to either T-CBT or a telephone-delivered pain psychoeducational active control condition (T-Ed). Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.004DOI Listing
January 2019
24 Reads

Design and methodology of a cluster-randomized trial in early care and education centers to meet physical activity guidelines: Sustainability via Active Garden Education (SAGE).

Contemp Clin Trials 2019 Feb 12;77:8-18. Epub 2018 Dec 12.

Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.

Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children. This manuscript describes the design and methodology of Sustainability via Active Garden Education (SAGE), a 12-session cluster-randomized controlled crossover design trial using community-based participatory research (CBPR) to test a garden-based ECEC physical activity and fruit and vegetables promotion intervention for young children aged 3-5 years in 20 sites. The SAGE curriculum uses the plant lifecycle as a metaphor for human development. Read More

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http://dx.doi.org/10.1016/j.cct.2018.12.003DOI Listing
February 2019
12 Reads
1.986 Impact Factor

Remission from chronic opioid use-Studying environmental and socio-economic factors on recovery (RECOVER): Study design and participant characteristics.

Contemp Clin Trials 2019 Jan 30;76:93-103. Epub 2018 Nov 30.

Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States. Electronic address:

Few opioid use disorder (OUD) treatment studies measure meaningful life changes during long-term recovery, focusing instead on retention and abstinence. Here, we report on the design and participant characteristics of the RECOVER study, a study exploring life changes in persons with OUD for up to 24 months following participation in a Phase III trial evaluating buprenorphine extended-release monthly injection for subcutaneous use (known as RBP-6000 during development). This multisite, observational, cohort study tracks clinical, environmental, and socio-economic changes using self-administered assessments, urine drug screens (UDS), and public databases. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.015DOI Listing
January 2019
13 Reads

Diabetes sleep treatment trial: Premise, design, and methodology.

Contemp Clin Trials 2019 Jan 2;76:104-111. Epub 2018 Dec 2.

University of Pittsburgh School of Nursing, 3500 Victoria Street, Pittsburgh, PA, United States.

The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, randomized, sham-controlled trial. The study objective is to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) treatment results in improved glycemic control and diabetes self-management behavior compared to participants on a sham-CPAP (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and co-morbid OSA. The purpose of this paper is to describe the premise for the DSTT, the study design, and the methodology used in this on-going trial. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6311443PMC
January 2019
3 Reads

The weWomen and ourCircle randomized controlled trial protocol: A web-based intervention for immigrant, refugee and indigenous women with intimate partner violence experiences.

Contemp Clin Trials 2019 Jan 2;76:79-84. Epub 2018 Dec 2.

Johns Hopkins University School of Nursing, 525 N Wolfe Street, Baltimore MD-21205, USA. Electronic address:

Intimate partner violence (IPV), including homicides is a widespread and significant public health problem, disproportionately affecting immigrant, refugee and indigenous women in the United States (US). This paper describes the protocol of a randomized control trial testing the utility of administering culturally tailored versions of the danger assessment (DA, measure to assess risk of homicide, near lethality and potentially lethal injury by an intimate partner) along with culturally adapted versions of the safety planning (myPlan) intervention: a) weWomen (designed for immigrant and refugee women) and b) ourCircle (designed for indigenous women). Safety planning is tailored to women's priorities, culture and levels of danger. Read More

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January 2019
6 Reads
1.986 Impact Factor

Shake Rattle & Roll - Design and rationale for a pragmatic trial to improve blood pressure control among blacks with persistent hypertension.

Contemp Clin Trials 2019 Jan 28;76:85-92. Epub 2018 Nov 28.

Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.

Background: In Kaiser Permanente Northern California (KPNC), members had similar access to care and a very high overall rate of hypertension control. However, blacks had poorer blood pressure (BP) control than whites. The Shake Rattle & Roll (SRR) trial aimed to improve BP control rates in blacks and to reduce disparities in hypertension control. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.012DOI Listing
January 2019
2 Reads

Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).

Contemp Clin Trials 2019 Jan 22;76:120-131. Epub 2018 Nov 22.

Division of Medical Oncology, Duke University, Durham, NC, United States. Electronic address:

Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6346744PMC
January 2019
11 Reads

Pediatric continuity care intensivist: A randomized controlled trial.

Contemp Clin Trials 2019 Jan 20;76:72-78. Epub 2018 Nov 20.

Children's Hospital of Philadelphia, Philadelphia, PA, United States.

Introduction: Long-stay critically ill patients in the Pediatric Intensive Care Unit (PICU) may be at risk for inconsistencies in treatment plan, delay in plan progression, and patient/family dissatisfaction with communication. This article describes the development and evaluation of an intervention designed to improve continuity and communication delivered by continuity PICU attendings.

Methods And Analysis: A randomized controlled trial of an intervention in one PICU that was randomized at the patient level. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.011DOI Listing
January 2019
16 Reads

The Healthy Weigh study of lottery-based incentives and environmental strategies for weight loss: Design and baseline characteristics.

Contemp Clin Trials 2019 Jan 26;76:24-30. Epub 2018 Oct 26.

University of Pennsylvania Center for Health Incentives and Behavioral Economics, 423 Guardian Drive, 11th Floor Blockley Hall, Philadelphia, PA 19104, United States. Electronic address:

Identifying effective strategies for treating obesity is a clinical challenge and a public health priority. The present study is an innovative test of the relative effectiveness of lottery-based financial incentives and environmental strategies on weight loss and maintenance. The Healthy Weigh study is evaluating the comparative effectiveness of behavioral economic financial incentives and environmental strategies, separately and together, in achieving initial weight loss and maintenance of weight loss, in obese urban employee populations. Read More

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January 2019
7 Reads

Rationale and design for eHealth Familias Unidas Primary Care: A drug use, sexual risk behavior, and STI preventive intervention for hispanic youth in pediatric primary care clinics.

Contemp Clin Trials 2019 Jan 17;76:64-71. Epub 2018 Nov 17.

Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Prevention Implementation Methodology (Ce-PIM), Northwestern University, Chicago, IL, USA.

Family-based behavioral interventions are efficacious and effective in preventing drug use and sexual risk behaviors; unfortunately, they have not been evaluated and disseminated in pediatric primary care practice, where they can have a significant impact. There is an increased focus on integrating parenting interventions into primary care to reduce health disparities among ethnic minorities such as Hispanics. Although Hispanic youth demonstrate higher levels of drug use and sexual risk behaviors than their non-Hispanic counterparts, few parenting interventions are available for Hispanic youth, and none have been delivered specifically to Hispanic adolescents in primary care. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6331011PMC
January 2019
25 Reads

Fit & quit: An efficacy trial of two behavioral post-cessation weight gain interventions.

Contemp Clin Trials 2019 Jan 13;76:31-40. Epub 2018 Nov 13.

Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N. Pauline St., Memphis, TN 38163, USA.

While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7 kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.009DOI Listing
January 2019
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Rationale and design of the Hepatocellular carcinoma Early Detection Strategy study: A multi-center longitudinal initiative of the National Cancer Institute's Early Detection Research Network.

Contemp Clin Trials 2019 Jan 12;76:49-54. Epub 2018 Nov 12.

Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd 7S, Philadelphia, PA, 19104, USA. Electronic address:

Background: Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.008DOI Listing
January 2019
5 Reads
1.990 Impact Factor

Attentional bias modification treatment for depression: Study protocol for a randomized controlled trial.

Contemp Clin Trials 2018 Dec 26;75:59-66. Epub 2018 Oct 26.

University of Texas at Austin, USA.

Theoretical models and empirical research point to negatively biased attention as a maintaining factor in depression. Although preliminary studies suggest experimentally modifying attentional biases (i.e. Read More

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http://dx.doi.org/10.1016/j.cct.2018.10.014DOI Listing
December 2018
2 Reads

Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.

Contemp Clin Trials 2019 Jan 8;76:1-8. Epub 2018 Nov 8.

Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Introduction: The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs.

Methods And Analyses: We are conducting randomized trials of real incentives embedded within two parent RCTs. Read More

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http://dx.doi.org/10.1016/j.cct.2018.11.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6354250PMC
January 2019
17 Reads

Design of ChooseWell 365: Randomized controlled trial of an automated, personalized worksite intervention to promote healthy food choices and prevent weight gain.

Contemp Clin Trials 2018 Dec 7;75:78-86. Epub 2018 Nov 7.

Harvard Medical School, Boston, MA, United States; Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States. Electronic address:

Background/aims: Behavioral nudges in the food environment increase healthy choices, but it is unknown if they improve diet and health. The ChooseWell 365 study will determine if an automated, personalized worksite intervention to nudge healthier choices improves overall diet and cardiometabolic health.

Design: Randomized controlled trial of 602 hospital employees who regularly use on-site cafeterias and pay with an employee ID. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183041
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http://dx.doi.org/10.1016/j.cct.2018.11.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6258180PMC
December 2018
12 Reads

Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling.

Contemp Clin Trials 2019 Jan 6;76:55-63. Epub 2018 Nov 6.

University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA.

Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S15517144183043
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http://dx.doi.org/10.1016/j.cct.2018.11.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6311420PMC
January 2019
7 Reads