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Clinical Research

Evelina Cardoso, Thomas Mercier, Anna Dorothea Wagner, Krisztian Homicsko, Olivier Michielin, Kim Ellefsen-Lavoie, Laurène Cagnon, Manuel Diezi, Thierry Buclin, Nicolas Widmer, Chantal Csajka, Laurent Decosterd
A sensitive and selective method of high performance liquid chromatography (HPLC) coupled to tandem mass spectrometry (MS/MS) has been developed for the simultaneous quantification of six anticancer protein kinase inhibitors (PKIs), dabrafenib, trametinib, vemurafenib, cobimetinib, pazopanib, regorafenib, and two active metabolites (regorafenib-M2 and regorafenib-M5) in human plasma. Plasma protein precipitation with methanol enables the sample extraction of 100 μL aliquot of plasma. Analytes are detected by electrospray triple-stage quadrupole mass spectrometry and quantified using the calibration curves with stable isotope-labeled internal standards...
February 8, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Katherine B Carnelley, Mona-Maria Bejinaru, Lorna Otway, David S Baldwin, Angela C Rowe
BACKGROUND: The aim of this study was to assess the potential effectiveness of secure attachment priming in outpatients with depressive disorders. METHODS: Forty-eight participants engaged in secure attachment priming or neutral priming in the laboratory (Time 1), after which they received three daily consecutive primes via text message (Times 2-4), aimed at maintaining the effects from Time 1. A follow-up one day later (Time 5) was also included. Dependent measures were assessed at Times 1, 4 and 5...
March 12, 2018: Journal of Affective Disorders
Angus Fayia Tengbeh, Luisa Enria, Elizabeth Smout, Thomas Mooney, Mike Callaghan, David Ishola, Bailah Leigh, Deborah Watson-Jones, Brian Greenwood, Heidi Larson, Shelley Lees
The 2014-2016 Ebola epidemic presented a challenging setting in which to carry out clinical trials. This paper reports findings from social science research carried out in Kambia, Northern Sierra Leone during first year of an Ebola vaccine trial (August 2015-July 2016). The social science team collected data through ethnographic observation, 42 in depth interviews; 4 life narratives; 200 exit interviews; 31 key informant interviews; and 8 focus group discussions with trial participants and community members not enrolled in the trial...
March 5, 2018: Social Science & Medicine
Brenda Si Elias, Ana Hanlon-Dearman, Betty Head, Geoffrey G Hicks
Translating to the Community (T2C) is a social bio-repository designed to advance new diagnostic tools and realign community-clinical processes, with the aim to mitigate the short-and-long term impacts of Fetal Alcohol Spectrum Disorder (FASD), prenatal alcohol exposure, and its co-morbidities and behaviors. In this paper, we describe the evolution of this repository as a new translational partnership to advance a precision medicine approach to FASD. Key to its evolution was a partnership between academic researchers, Indigenous communities, families and a regional diagnostic clinic...
March 15, 2018: Biochemistry and Cell Biology, Biochimie et Biologie Cellulaire
Jeff M Michalski, Jennifer Moughan, James Purdy, Walter Bosch, Deborah W Bruner, Jean-Paul Bahary, Harold Lau, Marie Duclos, Matthew Parliament, Gerard Morton, Daniel Hamstra, Michael Seider, Michael I Lock, Malti Patel, Hiram Gay, Eric Vigneault, Kathryn Winter, Howard Sandler
Importance: Optimizing radiation therapy techniques for localized prostate cancer can affect patient outcomes. Dose escalation improves biochemical control, but no prior trials were powered to detect overall survival (OS) differences. Objective: To determine whether radiation dose escalation to 79.2 Gy compared with 70.2 Gy would improve OS and other outcomes in prostate cancer. Design, Setting, and Participants: The NRG Oncology/RTOG 0126 randomized clinical trial randomized 1532 patients from 104 North American Radiation Therapy Oncology Group institutions March 2002 through August 2008...
March 15, 2018: JAMA Oncology
Frank Niemeyer, Lutz Claes, Anita Ignatius, Nicholaus Meyers, Ulrich Simon
Distraction osteogenesis is an effective method for generating large amounts of bone in situ for treating pathologies such as large bone defects or skeletal malformations, for instance leg-length discrepancies. While an optimized distraction procedure might have the potential to reduce the rate of complications significantly, our knowledge of the underlying mechanobiological processes is still insufficient for systematic optimization of treatment parameters such as distraction rate or fixation stiffness. We present a novel numerical model of lateral distraction osteogenesis, based on a mechanically well-controlled in vivo experiment...
2018: PloS One
Wendy A Davis, David G Bruce, Milan Dragovic, Timothy M E Davis, Sergio E Starkstein
BACKGROUND: Previous research using latent class analysis (LCA) identified classes of people with type 2 diabetes and specific profiles of depression and anxiety. Since LCA-derived anxious depression strongly predicts cardiovascular outcomes and mortality but cannot be applied to individuals, we developed a validated combined depression-anxiety metric, the Diabetes Anxiety Depression Scale (DADS), for potential clinical application in people with type 2 diabetes. METHODS: 1,337 participants with type 2 diabetes from the observational community-based Fremantle Diabetes Study Phase II completed the Patient Health Questionnaire 9-item version (PHQ-9) to assess symptoms of depression, and the Generalised Anxiety Disorder Scale (GADS) to assess symptoms of anxiety...
2018: PloS One
Lisa Blom, Lucie Laflamme, Helle Mölsted Alvesson
BACKGROUND: Image-based teleconsultation between medical experts and healthcare staff at remote emergency centres can improve the diagnosis of conditions which are challenging to assess. One such condition is burns. Knowledge is scarce regarding how medical experts perceive the influence of such teleconsultation on their roles and relations to colleagues at point of care. METHODS: In this qualitative study, semi-structured interviews were conducted with 15 medical experts to explore their expectations of a newly developed App for burns diagnostics and care prior to its implementation...
2018: PloS One
Kateřina Štulíková, Marcel Karabín, Jakub Nešpor, Pavel Dostálek
Hop ( Humulus lupulus L.), as a key ingredient for beer brewing, is also a source of many biologically active molecules. A notable compound, 8-prenylnaringenin (8-PN), structurally belonging to the group of prenylated flavonoids, was shown to be a potent phytoestrogen, and thus, became the topic of active research. Here, we overview the pharmacological properties of 8-PN and its therapeutic opportunities. Due to its estrogenic effects, administration of 8-PN represents a novel therapeutic approach to the treatment of menopausal and post-menopausal symptoms that occur as a consequence of a progressive decline in hormone levels in women...
March 15, 2018: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
B M Kamath, A Baker, R Houwen, L Todorova, N Kerkar
BACKGROUND: Alagille syndrome (ALGS) is an inherited multisystem disorder typically manifesting as cholestasis, and potentially leading to end-stage liver disease and death. AIM: To perform the first systematic review of the epidemiology, natural history and burden of ALGS with a focus on the liver component. METHODS: Electronic databases and proceedings from key congresses were searched in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2009 guidelines...
March 14, 2018: Journal of Pediatric Gastroenterology and Nutrition
Daniel L Riddle, Mark P Jensen, Dennis Ang, James Slover, Robert Perera, Levent Dumenci
BACKGROUND: Pain-coping strategies and appraisals are responses to the pain experience. They can influence patient-reported and physical performance outcome measures in a variety of disorders, but the associations between a comprehensive profile of pain-coping responses and preoperative pain/function and physical performance measures in patients scheduled for knee arthroplasty have not been examined. Patients with moderate to high pain catastrophizing (a pain appraisal approach associated with an exaggerated focus on the threat value of pain) may represent an excellent study population in which to address this knowledge gap...
April 2018: Clinical Orthopaedics and related Research
Young Hak Roh, Young Do Koh, Jong Oh Kim, Kyu Ho Lee, Hyun Sik Gong, Goo Hyun Baek
BACKGROUND: Postoperative pillar pain (deep-seated wrist pain worsened by leaning on the heel of the hand) sometimes occurs after carpal tunnel release (CTR), leading to weakness in the hand and delayed return to work. Increased pain sensitivity has been found to be associated with worse symptoms and poorer treatment response in a number of chronic musculoskeletal conditions, but few studies have investigated the association of pain sensitization with pillar pain after CTR. QUESTIONS/PURPOSES: (1) Is preoperative pain sensitization in patients with carpal tunnel syndrome (CTS) associated with increased severity of pillar pain after open CTR? (2) What other demographic, electrophysiological, or preoperative clinical characteristics are associated with pillar pain after CTR? METHODS: Over a 35-month period, one surgeon performed 162 open carpal tunnel releases...
April 2018: Clinical Orthopaedics and related Research
Enrique Bernal, Jose Miguel Gómez, Inma Jarrín, Alfredo Cano, Angeles Muñoz, Antonia Alcaraz, Arkaitz Imaz, Jose Antonio Iribarren, María Rivero, Piedad Arazo, Félix Gutiérrez, CoRIS Study Group
BACKGROUND: The objetive was investigate the long-term impact of low level viremia (LLV) on all-cause mortality, AIDS and non-AIDS events (NAEs), and virological failure in patients receiving ART. METHODS: We analyzed ART-naïve adults from the cohort of the Spanish AIDS Research Network (CoRIS) who initiated ART from 2004 to 2015 and achieved plasma viral load (VL) below 50 copies/ml. LLV50-199 was defined as two consecutive VL between 50 and 199 copies/ml, and LLV200-499 as two consecutive VL between 50 and 499 copies/ml with at least one between 200 and 499 copies/ml...
March 13, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Justyna Bartoszko, Duminda N Wijeysundera, Keyvan Karkouti, Jeannie Callum, Vivek Rao, Mark Crowther, Hilary P Grocott, Ruxandra Pinto, Damon C Scales, Blaine Achen, Sukhpal Brar, Doug Morrison, David Wong, Jean S Bussières, Tonya de Waal, Christopher Harle, Étienne de Médicis, Charles McAdams, Summer Syed, Diem Tran, Terry Waters
BACKGROUND: Research into major bleeding during cardiac surgery is challenging due to variability in how it is scored. Two consensus-based clinical scores for major bleeding: the Universal definition of perioperative bleeding and the European Coronary Artery Bypass Graft (E-CABG) bleeding severity grade, were compared in this substudy of the Transfusion Avoidance in Cardiac Surgery (TACS) trial. METHODS: As part of TACS, 7,402 patients underwent cardiac surgery at 12 hospitals from 2014 to 2015...
March 15, 2018: Anesthesiology
Ji Yeon Hong, Eun Ja Choi, Sun Young Choi, Kapsok Li, Beom Joon Kim
BACKGROUND: Comparative research on the characteristics of filler products is limited, especially in the preclinical analysis of hyaluronic acid (HA) fillers. OBJECTIVE: This study was performed to compare the preclinical characteristics, clinical efficacy, and safety of a new HA filler, IDHF-001, with Restylane SubQ in the treatment of nasolabial folds (NLFs). METHODS: Viscoelasticity and injection force were evaluated. Ninety-one subjects were enrolled in this randomized, patient/evaluator-blind, intraindividual clinical study...
March 13, 2018: Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [et Al.]
Cha-Nam Shin, Elizabeth Reifsnider, Darya McClain, Mihyun Jeong, David P McCormick, Michael Moramarco
BACKGROUND: Most Hispanic infants are fed formula during the first 6 weeks, and although 80% of Hispanic women initiate breastfeeding, rates of exclusive breastfeeding are much lower. Research aim: The purpose was to examine the influence of acculturation and cultural values on the breastfeeding practices of pregnant women of Mexican descent participating in the Special Supplemental Nutrition Program for Women, Infants, and Children who were enrolled in a prospective randomized clinical trial that aimed to reduce child obesity...
March 1, 2018: Journal of Human Lactation: Official Journal of International Lactation Consultant Association
Melissa V Chan, Paul C Armstrong, Timothy D Warner
While there are many bench and bedside tests to assess platelet reactivity, ex vivo light transmission aggregometry (LTA) remains the gold standard. LTA, however, is expensive, time-consuming and requires dedicated equipment and staff, making it impractical in many situations. In addition, there is significant variability between data generated at different testing sites meaning that tests often need to be repeated if a patient is transferred to the care of a different hospital. As such, there is clearly an unmet need for standardization of platelet testing...
March 15, 2018: Platelets
Steven L Sayers, Frances K Barg, Shahrzad Mavandadi, Tanya H Hess, Andreea Crauciuc
This concurrent embedded mixed methods study explored important aspects of communication occurring between military service members and their intimate partners during a combat deployment to Iraq or Afghanistan. Fifty-eight participants (32 military veterans and 26 non-veteran partners) participated in an interview using standardized self-report measures assessing the current level of relationship satisfaction, trauma symptoms of the veteran, and the veterans' trauma exposure. Participants also participated in a semistructured interview focused on combat deployment and reintegration experiences...
February 2018: Journal of Family Psychology: JFP
Ingrid K Weigold, Arne Weigold, Rebecca A Boyle, Caitlin A Martin-Wagar, Stephen Z Antonucci
Personal growth initiative has been shown to be an important predictor of psychological health. It is currently measured by the Personal Growth Initiative Scale-II (PGIS-II), which consists of 4 interrelated factors. Past research across various samples has consistently selected the 4-factor model as the best fit for the data compared to single-factor and second-order models. However, its fit has typically been adequate (not strong), and, to date, no research has examined alternate factor structures, such as a bifactor solution...
March 2018: Journal of Counseling Psychology
Bingbo Zhang, Wei Yan, Yanjing Zhu, Weitao Yang, Wenjun Le, Bingdi Chen, Rongrong Zhu, Liming Cheng
Patients are increasingly being diagnosed with neuropathic diseases, but are rarely cured because of the loss of neurons in damaged tissues. This situation creates an urgent clinical need to develop alternative treatment strategies for effective repair and regeneration of injured or diseased tissues. Neural stem cells (NSCs), highly pluripotent cells with the ability of self-renewal and potential for multidirectional differentiation, provide a promising solution to meet this demand. However, some serious challenges remaining to be addressed are the regulation of implanted NSCs, tracking their fate, monitoring their interaction with and responsiveness to the tissue environment, and evaluating their treatment efficacy...
March 15, 2018: Advanced Materials
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