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Contemporary Clinical Trials Communications

D A Khasho, S P J van Alphen, S M J Heijnen-Kohl, M A Ouwens, A Arntz, A C Videler
Background: The treatment of borderline personality disorder (BPD) has been examined extensively in adults up to the age of fifty in the past quarter of a century, but there is still a world to discover in treating BPD in older adults. The aim of the study is to investigate the effectiveness of schema therapy in older adults with BPD. Methods/design: A multiple baseline design is used in which participants are randomly assigned to baseline length. The primary outcome measure is assessed weekly and consists of the credibility of negative core beliefs...
June 2019: Contemporary Clinical Trials Communications
Simon Driver, Shannon Juengst, Evan Elizabeth McShan, Monica Bennett, Kathleen Bell, Rosemary Dubiel
Weight gain is prevalent among people with traumatic brain injury (TBI) and may be attributable to environmental or injury-specific factors such as mobility impairment, endocrine dysfunction, behavioral and emotional disorders, and sensory loss. Few weight management programs exist to meet the unique needs of this population. Researchers modified a nationally recognized, evidence-based weight-loss program, Group Lifestyle Balance™ (GLB), to address the needs of over-weight and obese people post TBI (GLB-TBI)...
June 2019: Contemporary Clinical Trials Communications
Andrew G Chapple, Janusz J Wojcik, Lee S McDaniel
An extension of the isotonic regression based phase I clinical trial design is presented that incorporates partial follow-up times into estimation of the raw toxicity probabilities. This phase I clinical trial design, called the TITE-IR design, drastically decreases average trial duration by allowing patients to be treated immediately after being enrolled in a phase I clinical trial. The TITE-IR design does not require specification of a prior skeleton of toxicity probabilities like the continual reassessment method, has an additional trial parameter for controlling aggressiveness of dose escalation, and has an easily understood formula for estimating toxicity probabilities...
June 2019: Contemporary Clinical Trials Communications
Nancy I Williams, Rebecca J Mallinson, Mary Jane De Souza
Purpose: Exercising women who consume inadequate energy relative to expenditure are at risk for downstream health consequences, such as menstrual cycle disturbances and poor bone health. Collectively, these conditions are known as the Female Athlete Triad (Triad). Clinicians often prescribe hormonal contraceptives to address this issue; however, the recommended treatment is reversal of the energy deficit. This paper describes the design of the REFUEL study, a randomized controlled trial (RCT) that explored the effectiveness of a 12-month intervention of increased energy intake on the reversal of an unhealthy energetic status and menstrual dysfunction and subsequent improvements in bone health in exercising women with severe menstrual cycle disturbances...
June 2019: Contemporary Clinical Trials Communications
Oreste Iocca, Alessio Farcomeni, Armando De Virgilio, Pasquale Di Maio, Paweł Golusinski, Luca Malvezzi, Raul Pellini, Wojciech Golusinski, Christopher H Rassekh, Giuseppe Spriano
Background: Lymph node involvement is a fundamental prognostic factor in head and neck squamous cell carcinoma (SCC). Lymph node yield (LNY), which is the number of lymph nodes retrieved after neck dissection, and lymph node ratio (LNR), which is the ratio of positive lymph nodes out of the total removed, are measurable indicators that may have the potential to be used as prognostic factors. The present study is designed to define the exact role of LNY and LNR regarding the overall and specific survival of patients affected by oral cavity and oropharyngeal SCC...
June 2019: Contemporary Clinical Trials Communications
Olayinka O Shiyanbola, Denise L Walbrandt Pigarelli, Elizabeth J Unni, Paul D Smith, Martha A Maurer, Yen-Ming Huang
Background: Improving medication adherence is one of the most effective approaches to improving the health outcomes of patients with diabetes. To date, enhancing diabetes medication adherence has occurred by improving diabetes-related knowledge. Unfortunately, behavior change often does not follow knowledge change. Enhancing communication between patients and healthcare professionals through addressing health literacy-related psychosocial attributes is critical. Objective: Examine whether a patient-centered intervention augmenting usual care with a health literacy-psychosocial support intervention will improve medication adherence for patients with diabetes, compared to usual care...
June 2019: Contemporary Clinical Trials Communications
Wendy E Hoy, Christopher M Reid, Molla Huq, Beverly J McLeod, Susan A Mott
Introduction: We conducted a double-blind randomised controlled trial in a remote-living Australian Aboriginal group at high risk for chronic disease to assess whether pharmacological treatment with angiotensin converting enzyme inhibitor (ACEi) could delay the onset of albuminuria, hypertension or diabetes in people currently free of those conditions. Methods: Eligibility criteria in 2008 were age ≥18yr, blood pressure ≤140/90 mm/Hg, urinary albumin creatinine ratio (ACR) < 3...
June 2019: Contemporary Clinical Trials Communications
Andrew McWilliams, Maximilian Schoen, Constance Krull, Justin Bilancia, Marguerite Bacon, Edwin Pena, Andrea McCall, Daniel Howard, Jason Roberge
Hospital care is the single, largest contributor to health spending, yet evidence to guide value transformation is lacking. The large, real-world studies required to fill this void are challenging to conduct in the complex and fast-paced acute care environment. To address these challenges, we created a framework that combines Lean manufacturing methodology and Applied Research principles. We deployed this framework to design, pilot, and iteratively improve a study protocol testing the effectiveness of an innovative care pathway for patients hospitalized with acute exacerbations of Chronic Obstructive Pulmonary Disease...
June 2019: Contemporary Clinical Trials Communications
Paige G Brooker, Sjaan R Gomersall, Neil A King, Michael D Leveritt
Background: The time of day that people exercise could have an influence on the efficacy of exercise for weight loss, via differences in adherence and/or physiological adaptations. However, there is currently no evidence to support an optimal time of day for exercise to maximise efficacy. Purpose: To examine the feasibility and acceptability of prescribed morning and evening exercise. Methods: Twenty inactive, overweight adults aged 18-60 years were recruited for a 12-week intervention and randomized to one of three groups using a 2:2:1 random allocation ratio: i) morning exercise (AM; n = 9); ii) evening exercise (PM; n = 7); or iii) waitlist control (CON; n = 4)...
June 2019: Contemporary Clinical Trials Communications
Steven D Targum, Christopher J Catania
Ratings surveillance is used in clinical trials to assure ratings reliability of site-based scores. One surveillance method employs audio-digital recordings of site-based clinician interviews to obtain remote, site-independent scores for assessment of paired scoring concordance and interview quality. We examined the utility of this surveillance strategy using paired site-independent scores derived from recorded site-based Montgomery-Asberg depression rating scale (MADRS) interviews obtained from patients with major depressive disorder (MDD) participating in 5 clinical trials...
June 2019: Contemporary Clinical Trials Communications
Ceilidh Nichols, Lynn E Kunkel, Robin Baker, Eve Jelstrom, Megan Addis, Kim A Hoffman, Dennis McCarty, P Todd Korthuis
Recent NIH policy stipulates that multi-site studies must use a single or IRB (Institutional Review Board) in order to streamline the review process while maintaining standards for human subjects protection. The Western States Node of the Clinical Trials Network (CTN) used a single IRB for protocol CTN-0067, a clinical trial testing the use of an opioid antagonist (extended-release naltrexone) versus opioid agonists (buprenorphine or methadone) for opioid use disorders among individuals living with HIV. This case study discusses the processes and challenges associated with use of a single IRB...
June 2019: Contemporary Clinical Trials Communications
Katie Baca-Motes, Alison M Edwards, Jill Waalen, Shawn Edmonds, Rajesh R Mehta, Lauren Ariniello, Gail S Ebner, Dimitri Talantov, John M Fastenau, Chureen T Carter, Troy C Sarich, Elise Felicione, Eric J Topol, Steven R Steinhubl
Objectives: The advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means. Methods: Candidate participants at possibly higher risk for atrial fibrillation were identified by means of a large insurance claims database and invited to participate in the study by their insurance provider...
June 2019: Contemporary Clinical Trials Communications
Zheng Su, Mark Stuntz
No abstract text is available yet for this article.
March 2019: Contemporary Clinical Trials Communications
Velia Leybas Nuño, Betsy C Wertheim, Bridget S Murphy, Richard A Wahl, Denise J Roe
No abstract text is available yet for this article.
March 2019: Contemporary Clinical Trials Communications
Paul Mackie, Gary Crowfoot, Heidi Janssen, David W Dunstan, Julie Bernhardt, F Rohan Walker, Amanda Patterson, Robin Callister, Neil J Spratt, Elizabeth Holliday, Coralie English
Excessive sitting is detrimentally associated with cardiovascular disease and all-cause mortality. Frequent breaks in prolonged sitting can improve cardiometabolic responses in non-stroke populations. However, this has not been established in stroke survivors. This study will determine the most effective dose of activity breaks that (i) produce clinically meaningful improvements in mean systolic blood pressure (primary outcome), postprandial glucose, and insulin responses (secondary outcomes), and (ii) is safe and feasible...
March 2019: Contemporary Clinical Trials Communications
Adam M Henrie, Mike R Sather, Ludmila N Bakhireva, James J Nawarskas, Kathy D Boardman, Grant D Huang
Knowing the extent to which a clinical trial's findings translate into clinical practice can be challenging. One practical approach to estimating a trial's influence on clinical practice can be achieved by assessing how the trial informed relevant clinical practice guidelines (CPGs). Accordingly, the objectives of this study were to provide an overview of all the clinical trials involving the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) that aimed at informing or resulted in informing the management of high blood pressure and to identify and describe the extent to which these trials informed CPGs for the management of high blood pressure...
March 2019: Contemporary Clinical Trials Communications
Diane M Flynn, Honor McQuinn, Alexandra Fairchok, Linda H Eaton, Dale J Langford, Tyler Snow, Ardith Z Doorenbos
Chronic pain significantly impairs physical, psychological and social functioning. Among military populations, pain due to injuries sustained both on and off the battlefield is a leading cause of short and long-term disability. Improving the quality of pain care for active duty service members is a major priority of the Department of Defense. This article describes an ongoing comparative effectiveness study which aims to (1) evaluate the benefit of a multimodal complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SRC) prior to an intensive functional restoration (FR) program compared to SRC alone, and (2) identify factors that predict improvement in pain impact following treatment completion...
March 2019: Contemporary Clinical Trials Communications
Lei Clifton, Jacqueline Birks, David A Clifton
We discuss different methods of sample size calculation for two independent means, aiming to provide insight into the calculation of sample size at the design stage of a parallel two-arm randomised controlled trial (RCT). We compare different methods for sample size calculation, using published results from a previous RCT. We use variances and correlation coefficients to compare sample sizes using different methods, including 1. The choice of the primary outcome measure: post-intervention score vs. change from baseline score...
March 2019: Contemporary Clinical Trials Communications
N G M Oonk, K L L Movig, E M Munster, K Koehorst-Ter Huurne, J van der Palen, L D A Dorresteijn
Background: Treatment of Parkinson's disease (PD) is symptomatic and frequently consists of complicated medication regimes. This negatively influences therapy adherence, resulting in lower benefit of treatment, drug related problems and decreased quality of life (QoL). A potential effective intervention strategy is a structured medication review, executed by community pharmacists. However, little is known about the effects on clinical endpoints like QoL, as well as on feasibility and cost-effectiveness in PD patients...
March 2019: Contemporary Clinical Trials Communications
Adam B Smith, Andria Hanbury, Jenny Retzler
The use of patient-reported outcome instruments (PRO) in clinical trials in order to capture the impacts of treatment on patients is widespread. However, regulatory agencies have over the past decade highlighted the need for PROs that are fit for purpose and target relevant aspects of the patient's condition. Many legacy PROs were developed with little patient input, are lengthy, and may lack relevance having not been modified or adapted as medical treatments have advanced. Computer-adaptive test (CAT) systems provide the possibility of targeted approaches to capturing patient-centric data, while minimising patient burden...
March 2019: Contemporary Clinical Trials Communications
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