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Impactful clinical trials

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https://www.readbyqxmd.com/read/28088681/maintenance-effects-of-working-memory-intervention-cogmed-in-children-with-symptomatic-epilepsy
#1
Amanda Fuentes, Elizabeth N Kerr
PURPOSE: To extend previous research documenting the benefits of working memory (WM) intervention (Cogmed) immediately post-intervention in children with epilepsy by assessing the 3-month maintenance effects. METHODS: Participants involved in a previous randomized clinical trial (RCT) were invited to participate if they completed Cogmed within the last 3months (n=15) and additional participants (n=13) were prospectively recruited. Standardized assessments of near-transfer effects (i...
January 12, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28087304/sleep-and-neurodegeneration-a-critical-appraisal
#2
REVIEW
Jagan A Pillai, James B Leverenz
Sleep abnormalities are clearly recognized as distinct clinical symptom of concern in neurodegenerative disorders. Appropriate management of sleep related symptoms has a positive impact on the quality of life of patients with neurodegenerative disorders. This review provides an overview of mechanisms that are currently being considered that tie sleep with neurodegeneration. It appraises the literature regarding specific sleep changes among common neurodegenerative diseases with a focus on Alzheimer's disease and synucleinopathies (i...
January 10, 2017: Chest
https://www.readbyqxmd.com/read/28087302/the-long-term-effect-of-bacille-calmette-gu%C3%A3-rin-vaccination-on-tuberculin-skin-testing-a-55-year-follow-up-study
#3
James D Mancuso, Rupal M Mody, Cara H Olsen, Lee H Harrison, Mathuram Santosham, Naomi E Aronson
BACKGROUND: Bacille Calmette-Guérin vaccination (BCG) is known to cause false positive tuberculin skin test (TST) results from cross-reactions to mycobacterial antigens. However, the duration of BCG influence on the TST is poorly characterized. The objective of the study was to assess the long-term effect of BCG vaccination on TST reactivity. METHODS: Data on TST reactivity were prospectively collected during 1935-47 as part of a clinical trial among American Indians / Alaskan Natives and retrospectively thereafter between 1948 and 1998...
January 10, 2017: Chest
https://www.readbyqxmd.com/read/28087295/postconditioning-induced-neuroprotection-mechanisms-and-applications-in-cerebral-ischemia
#4
REVIEW
Yan-Ying Fan, Wei-Wei Hu, Fang Nan, Zhong Chen
Ischemic postconditioning (PostC) is defined as a series of rapid intermittent interruptions of blood flow at the phase of reperfusion, which produces neuroprotection against cerebral ischemia/reperfusion injury via mobilizing the brain's own endogenous adaptive mechanisms. Now the concept of conventional ischemic PostC has been extended to limb remote ischemic PostC and chemical PostC with hypoxia, volatile anesthetic, CO2, etc. According to the different temporal profile of PostC, it is divided into rapid and delayed PostC...
January 10, 2017: Neurochemistry International
https://www.readbyqxmd.com/read/28087280/increased-homocysteine-levels-impair-reference-memory-and-reduce-cortical-levels-of-acetylcholine-in-a-mouse-model-of-vascular-cognitive-impairment
#5
Kevin Dam, Martina Füchtemeier, Tracy D Farr, Philipp Boehm-Sturm, Marco Foddis, Ulrich Dirnagl, Olga Malysheva, Marie A Caudill, Nafisa M Jadavji
Folates are B-vitamins that are vital for normal brain function. Deficiencies in folates either genetic (methylenetetrahydrofolate reductase, MTHFR) or dietary intake of folic acid result in elevated levels of homocysteine. Clinical studies have shown that elevated levels of homocysteine (Hcy) may be associated with the development of dementia, however this link remains unclear. The purpose of this study was to evaluate the impact of increased Hcy levels on a mouse model of vascular cognitive impairment (VCI) produced by chronic hypoperfusion...
January 11, 2017: Behavioural Brain Research
https://www.readbyqxmd.com/read/28087163/clinical-studies-of-ex-vivo-expansion-to-accelerate-engraftment-after-umbilical-cord-blood-transplantation-a-systematic-review
#6
REVIEW
Jeffrey Kiernan, Pauline Damien, Madeline Monaghan, Risa Shorr, Lauralyn McIntyre, Dean Fergusson, Alan Tinmouth, David Allan
Cell dose limits greater use of umbilical cord blood (UCB) in hematopoietic cell transplantation. The clinical benefits of ex vivo expansion need clarity to understand its potential impact. A systematic search of studies addressing UCB ex vivo expansion was conducted. Fifteen clinical studies (349 transplanted patients) and 13 registered trials were identified. The co-infusion of an expanded unit and a second unmanipulated unit (8 studies), the fractional expansion of 12% to 60% of a single unit (5 studies), and the infusion of a single expanded unit (2 studies) were reported...
December 23, 2016: Transfusion Medicine Reviews
https://www.readbyqxmd.com/read/28087133/secukinumab-sustains-early-patient-reported-outcome-benefits-through-1%C3%A2-year-results-from-2-phase-iii-randomized-placebo-controlled-clinical-trials-comparing-secukinumab-with-etanercept
#7
Bruce Strober, Alice B Gottlieb, Bintu Sherif, Patrick Mollon, Isabelle Gilloteau, Lori McLeod, Todd Fox, Margaret Mordin, Ari Gnanasakthy, Charis Papavassilis, Mark G Lebwohl
BACKGROUND: Psoriasis is a chronic condition with negative impact on patients' quality of life that most often requires lifelong effective and safe treatment. OBJECTIVE: This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis. METHODS: The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept...
January 10, 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28087128/intranasal-oxytocin-to-prevent-posttraumatic-stress-disorder-symptoms-a-randomized-controlled-trial-in-emergency-department-patients
#8
Mirjam van Zuiden, Jessie L Frijling, Laura Nawijn, Saskia B J Koch, J Carel Goslings, Jan S Luitse, Tessa H Biesheuvel, Adriaan Honig, Dick J Veltman, Miranda Olff
BACKGROUND: There are currently few preventive interventions available for posttraumatic stress disorder (PTSD). Intranasal oxytocin administration early after trauma may prevent PTSD, because oxytocin administration was previously found to beneficially impact PTSD vulnerability factors, including neural fear responsiveness, peripheral stress reactivity, and socioemotional functioning. Therefore, we investigated the effects of intranasal oxytocin administration early after trauma on subsequent clinician-rated PTSD symptoms...
December 8, 2016: Biological Psychiatry
https://www.readbyqxmd.com/read/28086943/a-lifestyle-intervention-among-elderly-men-on-active-surveillance-for-non-aggressive-prostate-cancer-a-randomised-feasibility-study-with-whole-grain-rye-and-exercise
#9
Anne Kirstine Eriksen, Rikke Dalgaard Hansen, Michael Borre, Ryan Godsk Larsen, Jeppe Munthe Jensen, Kristian Overgaard, Mette Borre, Cecilie Kyrø, Rikard Landberg, Anja Olsen, Anne Tjønneland
BACKGROUND: The prognosis for men with non-aggressive prostate cancer is good, and several studies have investigated the impact of lifestyle changes including physical activity and diet on the prognosis. Despite positive results in animal studies and a few human interventions with whole-grain rye on markers of prostate cancer progression, the feasibility of trials investigating such dietary changes in combination with physical activity remains largely unstudied. The primary aim was to investigate the feasibility of an intervention with high whole-grain rye intake and vigorous physical activity for 6 months in men diagnosed with prostate cancer...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086942/external-beam-radiotherapy-for-unresectable-hepatocellular-carcinoma-an-international-multicenter-phase-i-trial-sakk-77-07-and-sasl-26
#10
Evelyn Herrmann, Diana Naehrig, Manfred Sassowsky, Martin Bigler, Jeroen Buijsen, Ilja Ciernik, Daniel Zwahlen, Alessandra Franzetti Pellanda, Andreas Meister, Peter Brauchli, Simona Berardi, Erika Kuettel, Jean-François Dufour, Daniel M Aebersold
PURPOSE: To assess feasibility and safety of conventionally fractionated radiotherapy (cfRT) in patients with hepatocellular carcinoma (HCC). METHODS: Patients with histologically confirmed stage cT1-4, cN0-1 HCC and Child-Pugh Score (CPS) A or B disease were included in a phase I multicenter trial. Metastatic HCC were allowed if ≥90% of total tumor volume was located within the liver. Patients were enrolled onto five dose-escalation levels (54-70Gy in 2Gy fractions) based on a modified 3 + 3 design, with cohorts of five patients instead of three patients in dose levels 4 and 5...
January 13, 2017: Radiation Oncology
https://www.readbyqxmd.com/read/28086906/physical-activity-and-nutrition-behaviour-outcomes-of-a-cluster-randomized-controlled-trial-for-adults-with-metabolic-syndrome-in-vietnam
#11
Van Dinh Tran, Andy H Lee, Jonine Jancey, Anthony P James, Peter Howat, Le Thi Phuong Mai
BACKGROUND: Metabolic syndrome is prevalent among Vietnamese adults, especially those aged 50-65 years. This study evaluated the effectiveness of a 6 month community-based lifestyle intervention to increase physical activity levels and improve dietary behaviours for adults with metabolic syndrome in Vietnam. METHODS: Ten communes, involving participants aged 50-65 years with metabolic syndrome, were recruited from Hanam province in northern Vietnam. The communes were randomly allocated to either the intervention (five communes, n = 214) or the control group (five communes, n = 203)...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28081369/randomized-controlled-ethanol-cookstove-intervention-and-blood-pressure-in-pregnant-nigerian-women
#12
Donee Alexander, Amanda Northcross, Nathaniel Wilson, Anindita Dutta, Rishi Pandya, Tope Ibigbami, Damilola Adu, John Olamijulo, Oludare Morhason-Bello, Theodore Karrison, Oladosu Ojengbede, Christopher O Olopade
RATIONALE: Hypertension during pregnancy is a leading cause of maternal mortality. Exposure to household air pollution (HAP) elevates blood pressure (BP). OBJECTIVES: Investigate ability of clean cookstove intervention to lower BP during pregnancy. METHODS: A randomized, controlled trial (RCT) was conducted in Nigeria. Pregnant women cooking with kerosene or firewood were randomly assigned to ethanol (n = 162) or control arms (n = 162). BP measurements were taken during 6 antenatal visits...
January 12, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28079900/a-curated-gene-list-for-reporting-results-of-newborn-genomic-sequencing
#13
Ozge Ceyhan-Birsoy, Kalotina Machini, Matthew S Lebo, Tim W Yu, Pankaj B Agrawal, Richard B Parad, Ingrid A Holm, Amy McGuire, Robert C Green, Alan H Beggs, Heidi L Rehm
PURPOSE: Genomic sequencing (GS) for newborns may enable detection of conditions for which early knowledge can improve health outcomes. One of the major challenges hindering its broader application is the time it takes to assess the clinical relevance of detected variants and the genes they impact so that disease risk is reported appropriately. METHODS: To facilitate rapid interpretation of GS results in newborns, we curated a catalog of genes with putative pediatric relevance for their validity based on the ClinGen clinical validity classification framework criteria, age of onset, penetrance, and mode of inheritance through systematic evaluation of published evidence...
January 12, 2017: Genetics in Medicine: Official Journal of the American College of Medical Genetics
https://www.readbyqxmd.com/read/28079501/clinical-efficacy-of-oral-alendronate-in-ankylosing-spondylitis-a-randomised-placebo-controlled-trial
#14
Lucy Coates, Jonathan C Packham, Paul Creamer, Sarah Hailwood, Ashley S Bhalla, Kuntal Chakravarty, Diamuid Mulherin, Gordon Taylor, Derek L Mattey, Ashok K Bhalla
OBJECTIVES: A prospective, double blind, randomised, placebo controlled trial over 2 years was performed to test the efficacy of alendronate, an oral aminobisphosphonate, in improving symptoms and arrest disease progression in patients with mild to severe ankylosing spondylitis (AS). METHODS: 180 patients with AS were randomised to receive weekly alendronate 70 mg or placebo (1:1 randomisation). BAS-G was the primary outcome measure with Bath indices as secondary outcomes...
January 4, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28079291/prognostic-value-of-pd-l1-in-breast-cancer-a-meta-analysis
#15
Changjun Wang, Hanjiang Zhu, Yidong Zhou, Feng Mao, Yan Lin, Bo Pan, Xiaohui Zhang, Qianqian Xu, Xin Huang, Qiang Sun
Programmed cell death 1 ligand 1 (PD-L1) is a promising therapeutic target for cancer immunotherapy. However, the correlation between PD-L1 and breast cancer survival remains unclear. Here, we present the first meta-analysis to investigate the prognostic value of PD-L1 in breast cancer. We searched Pubmed, Embase, and Cochrane Central Register of Controlled Trials databases for relevant studies evaluating PD-L1 expression and breast cancer survival. Fixed- and random-effect meta-analyses were conducted based on heterogeneity of included studies...
January 12, 2017: Breast Journal
https://www.readbyqxmd.com/read/28077530/impact-of-balanced-tetrastarch-raw-material-on-perioperative-blood-loss-a-randomized-double-blind-controlled-trial
#16
A Joosten, R Tircoveanu, S Arend, P Wauthy, P Gottignies, P Van der Linden
BACKGROUND: As 6% hydroxyethyl starch (HES) 130/0.40 or 130/0.42 can originate from different vegetable sources, they might have different clinical effects. The purpose of this prospective, randomized, double-blind controlled trial was to compare two balanced tetrastarch solutions, one maize-derived and one potato-derived, on perioperative blood loss in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). METHODS: We randomly assigned 118 patients undergoing elective cardiac surgery into two groups, to receive either a maize- or a potato-derived HES solution...
October 2016: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28077151/multi-strategic-intervention-to-enhance-implementation-of-healthy-canteen-policy-a-randomised-controlled-trial
#17
Luke Wolfenden, Nicole Nathan, Lisa M Janssen, John Wiggers, Kathryn Reilly, Tessa Delaney, Christopher M Williams, Colin Bell, Rebecca Wyse, Rachel Sutherland, Libby Campbell, Christophe Lecathelinais, Chris Oldmeadow, Megan Freund, Sze Lin Yoong
BACKGROUND: Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. METHODS: Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group...
January 11, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28077047/extended-infusion-compared-to-standard-infusion-cefepime-as-empiric-treatment-of-febrile-neutropenia
#18
Rebekah H Wrenn, David Cluck, LeAnne Kennedy, Christopher Ohl, John C Williamson
Background Extended infusion (EI) dosing provides a longer time above the minimum inhibitory concentration, which is important for the clinical success of β-lactam antibiotics, especially for patients with impaired immunity. The aim of this study was to determine the feasibility and clinical impact of administering cefepime by EI as treatment of febrile neutropenia. Methods This was a prospective, randomized, comparative pilot study. All patients received cefepime 2 g IV every 8 h, with the first dose administered using a 30-min infusion...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28076638/the-future-of-psychiatric-research
#19
Marco Antonio Caldieraro
Psychiatric disorders place considerable burden on individuals and on public health. Funding for research in psychiatry is less than ideal, but even so high quality research is being conducted at many centers. However, these studies have not impacted clinical practice as much as expected. The complexity of psychiatric disorders is one of the reasons why we face difficulties in translating research results to patient care. New technologies and improved methodologies are now available and must be incorporated to deal with this complexity and to accelerate the translational process...
October 2016: Trends in Psychiatry and Psychotherapy
https://www.readbyqxmd.com/read/28075160/can-we-accomplish-better-oncological-results-with-robot-assisted-radical-prostatectomy
#20
Ali Riza Kural, Can Obek, Tünkut Doğanca
Surgical removal with radical prostatectomy has been a cornerstone for the treatment of prostate cancer and is associated with level one evidence for survival advantage compared to watchful waiting. Since the first structured robotic program was launched in 2000, robot-assisted radical prostatectomy (RARP) has had a rapid diffusion and surpassed its open (ORP) and laparoscopic (LRP) counterparts in the United States and is progressively expanding in other countries. Interestingly, this common acceptance of RARP was initially driven in the paucity of robust clinical evidence...
January 11, 2017: Journal of Endourology
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